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    HEVA Business Partner Purpose of Role: To support rare disease portfolio and to plan and generate robust health economics and value based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod. Major Activities / Key Responsibilities Health Economics strategy, evidence generation and reimbursement support Deliver quality research projects, economic models, trial design recommendations and other activities in support of programs/products. The incumbent interfaces with Clinical, Medical Affairs and business partners including Marketing, External Affairs and Market Access. He/she is accountable for the planning, design, implementation and completion of innovative evidence based research programs that are consistent with program/product strategies. The research programs developed will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle. (Note: The list below is not comprehensive; this job is also responsible for other duties as assigned). Minimum requirements within this job function: Develops strategies and provides new ideas and concepts on how to move the program, product or therapeutic franchise forward Build research strategy to address the gaps in evidence generation Identify novel research applications to support product value proposition Manage the HEVA evidence generation strategy Develop research plan to support pre-launch, launch and post-launch evidence for investigational and marketed drugs Evidence generation plan includes burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, development and analysis of patient-reported outcomes Execute approved HEVA studies and manage ongoing studies according to budget and timeline expectations Manage and execute research studies to support the clinical, economic and humanistic value of products Studies include but are not limited to burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes Identify new HEVA evidence generation opportunities to maximize lifecycle management Develop and execute on HEOR plan for marketed products to generate robust post-marketing evidence Assist countries in developing or adapting health economic models and other materials for reimbursement, payer objection handling and other purposes Create dossiers and economic models that support access and reimbursement of products globally Deliverables include but are not limited to core value dossiers, AMCP dossier (US only), budget impact models (BIM) and cost-effectiveness models (CEA) Develop and maintain effective relationships with key internal stakeholders including North American Medical Affairs, European Medical Affairs, Sanofi Emerging Market regional teams, and Established Products. Sets strategic evidence generation priorities and direction for assigned responsibilities and is able to incorporate this into appropriate planning documents Takes a leadership role in the development of relationships and continued advocacy with external advisors in appropriate therapeutic areas Collaborate with recognized subject matter experts (SMEs) and key opinion leaders (KOLs) including clinicians and health economists Co-develop and author research publications with SMEs and KOLs Develops collaborative research relationships that provide data of value to decision makers. Leverages interactions to identify strategies that will improve the impact of research and build advocates for data Establish relationships with patients and patient advocacy groups Generate and disseminate findings related to value of products for patients, physicians, payers and regulatory authorities Interacts with senior level management providing high level strategies and long term vision of assigned work Implementation of evidence generation tactics consistent with HEVA strategic goals including designing, budgeting, contracting, tracking, reporting, and publication plans Manage HEOR research projects within timelines and budget Disseminate, present and publish research abstracts and manuscripts in key conferences and journals Provides input to clinical and medical teams regarding opportunities to execute HEVA strategies within their planned research activities by identifying the appropriate evidence to collect and report Support the clinical development team in determining the appropriate endpoints for clinical trials Review studies conducted by the medical affairs team and provide subject matter guidance with respect to HEOR concepts Serves as a resource to commercial organization in terms of pricing, positioning and reimbursement of products based on economic evaluations Train and educate the internal teams on the use of economic evidence to support product pricing and reimbursement All incumbents are expected to demonstrate effective communication, organizational and interpersonal skills to be able to work effectively as part of a multidisciplinary team. The incumbent is expected to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law. Key Performance Indicators Demonstrated contributions to product success Development and execution of strategies that address data gaps and customer needs and ensure strategies and tactics anticipate scientific, regulatory and reimbursement/access trends and events that will affect Sanofi’s standing as a valued healthcare partner Expertise recognized within the function, corporation and healthcare field Develops and maintains peer relationships with clinical and economic methods Anticipates communication needs to cross-divisional audiences and pre-empts issues with timely and effective action Established track record of scientific and/or methods publications in peer-reviewed journals Compliance with all relevant internal SOPs and external laws and regulations. Basic Qualifications: Strong strategic and analytical skills to translate clinical and economic information and messages into payer evidence strategies. Strong customer focus Ability to work well in a cross-functional team Understanding of the disease environment and the evolution of the market access landscape and implications for the business At least 7 years of experience in HEOR or market access in pharmaceutical industry, CRO or academic experience Global experience is a must Proven track record working successfully in a project/matrix-oriented environment Strategic mindset and proven innovation/out of the box thinking in evidence generation/value documentation Excellent communication skills and ability to understand and present complex information in digestible ways for internal (e.g. senior management) and external audiences Strong team spirit, sense of transversally, multicultural awareness and ability to drive matrix teams Required experiences: Understands reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (e.g., providers, patients, health systems) Knowledge of methods and principles of health economics, health technology assessment (HTA) reviews Systematically reviewed available scientific evidence to identify clinical needs of the payer Provided timely and strategic recommendations to clinical development programs aimed at ensuring differentiation for payer value demonstration Translated Target Value Propositions and access strategies into evidence hypotheses, requirements and generation plans addressing payer/provider/health system unmet needs Understands, creates and applies relevant methods (e.g., observational data, post hoc analysis of clinical trials, meta-analysis, indirect comparison, etc..) to demonstrate product value potential Has created and applied state-of-the-art decision analyses in order to meet payer/provider methodological best practices Understands the risks and opportunities deriving from generating Real World Evidence Education: Advanced degree (Doctoral or Masters level) in relevant field Demonstrated understanding disease physiopathology, drug mechanism of action, clinical development principles, epidemiology, biostatistics, statistical programming, patient-reported outcome development, systemic literature reviews, network meta-analyses Languages: English fluent required Key Interfaces: Internal: External Affairs – Market Access, Public Affairs, Communications Global Market Access, US Market Access, Global Value & Access, Global Pricing and HEVA – headquarters and affiliates Medical Affairs - GBUs, affiliates, RW Evidence and Analytics, Clinical Outcomes Generation R&D – Global project teams and Clinical Affairs Regulatory Affairs, Compliance and Legal External: Payers/Reimbursement Authorities KOLs HTAs and other review bodies Pursue Progress. Discover Extraordinary Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Our Team This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. Job Description This position reports to the US Senior Medical Director, Immunology. Main job responsibilities Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned immunology products. Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access and Regulatory partners. Lead medical and scientific advisory boards to capture insights and translate into medical strategy. Provide disease state and product training to internal and external stakeholders. Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations. Support the execution of US Phase IIIB - IV clinical study programs. Support the review and approval of IST concepts/protocols according to applicable SOPs. Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals. Develop and maintain close professional relationships with Key Thought Leaders (healthcare practitioners and researchers) within the medical and scientific community. About you Education: Advanced degree in a scientific discipline: MD, PhD, PharmD Work Experience: Significant experience in Medical Affairs Launch and Life Cycle Management activities. Strong track record in developing and executing medical strategies in the US. Skills / knowledge: Knowledge of clinical development. Scientific acumen. In-depth understanding of the scientific method and ability to apply this information for business needs based on medical and scientific rationale. Relationships and Influence. Effective internal and external stakeholder management, politically astute with strong cross-functional teamwork and collaboration. Strategic thinking. Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities. Ability to translate innovative strategies or solutions into actionable plans Result orientation. Driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    The Associate Director, Systems Training will be responsible for strategic planning and implementation of all department Systems training (including but not limited to iCareConnect (Salesforce) , iCare Events (Veeva), and Five9 (telephony). This will include programs design and execution via eLearning, live meetings, virtual and on demand training courses, for the Rare Blood Disorders Patient Support Services (PSS) team. This individual will be responsible for development and delivery of content and will mentor and collaborate with a systems champion support network through a train-the-trainer model. The AD, Systems Training will work directly with PSS senior leadership and key PSS stakeholders to evaluate and continuously improve existing internal training and programs. The position will actively gather stakeholder feedback as it relates to internal process mapping and developing strategic training plans and content to bring enhanced educational awareness to stakeholders. The AD Systems Training will gain a full understanding of all system and business processes, so best practices can be outlined for employees and tailored to their usage and requirements. Key Responsibilities: Planning, designing, and delivering both large and small-scale trainings for new hires, business users and subject matter experts across functions in Rare Blood Disorders PSS on current systems and all updated functionality Working directly with PSS leadership to determine best practices, leverage learnings across PSS and continuously improve tool adoption Providing a high level of strategic analysis and planning with the ability to work with and manage demands and expectations from multiple internal customers Keep abreast of all project updates/product upgrade releases Establishing and implementing key metrics to track and communicate level of value and impact of training initiatives to all stakeholders Owning the on-the-ground execution and deployment of training experiences including office hours/lunch and learns Developing and delivering trainings both face-to-face and virtual; training subject matter experts who will serve as trainers Assessing activities across Rare Blood Disorders Functions and identifying opportunities for improved training outreach to the business including communication strategy Maintaining a library of multi-media support materials, including training guides, videos, and e-learnings Creating/curate new training materials as needed to support new functionality and requests from the business, leveraging off the shelf Salesforce training Working collaboratively with the PSS Operations Team, PSS Trainingteam and key stakeholders to manage the change communication for PRM/Systems platforms that impact stakeholder use Collaborate with Project/Platform/Patient Services subject matter experts to address training needs related to impacted processes and procedures. Document user issues and escalate them to Product Owner or Technical resource Management of Training Environments including the ability to manage/configure training environments Cambridge, MA, US based position, hybrid working with at least 2 days in office per week. Basic Qualifications: Bachelor's Degree required The ideal candidate will have 5+ years of relevant pharmaceutical/biotech industry experience with at least 2 years leading training programs Knowledge of Salesforce/Veeva platforms required Excellent communications skills, both verbal and written, with the ability to digest complex business processes and distill them down to their simplest forms Experience in the development, maintenance, and administration of e-learning materials & training programs Experience training adult learners on software products/systems Exhibits a high level of energy and enthusiasm and ability to work within a dynamic environment Promotes a good working relationship with leadership and subject matter experts Proactive in nature with the ability to encourage and motivate others Excellent planning, project management and organizational skills Continually demonstrates a level of integrity and professional demeanor in keeping with the Company's mission and values Travel required, approximately 20% Preferred Qualifications: Experience with Salesforce Health Cloud and VEEVA platforms Experience launching new PRM/CRM platforms Demonstrated ability to work in a highly matrixed environment with multiple cross-functional partners Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    JOB DESCRIPTION The Early Neuro-Development Global Program Head (GPH) is a key position that oversees early development activities in the Neurology & Ophthalmology Development (NOD) and is responsible for shaping strategy as well as managing execution. This is a highly visible role that will work closely with the Research and Development Heads in the Therapeutic Area to build and expand the early portfolio in Neurology. Unlike other GPH roles, this role is focused on multiple projects from IND-enabling studies to first in human studies and successful proof of concept trials. New programs come from the internal research pipeline and from in-licensing. The Early Development GPH is a critical contributor for the selection of projects to move forward and will drive execution of projects until they have achieved proof of concept and can be handed over to a later stage global program teams (GPT’s). At Sanofi we chase the miracles of science. Sanofi believes that the more we understand about disease pathogenesis in the human nervous system, the greater the chance we can produce life-changing therapies. Over the next five years, Sanofi plans to regularly test in the clinic potentially disease-modifying treatments for Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Parkinson’s Disease, Amyotrophic Lateral Sclerosis (ALS), and Genetic diseases such Metachromatic Leukodystrophy (MLD), as well as other CNS diseases. Scientific excellence, integrative thinking and strong interpersonal skills will be required to succeed in this role. The Early Development GPH reports to Nazem Atassi, MD, Head of Early Neuro Development within NOD. The plan is for the incumbent to initially have one direct report although this will likely increase as the pipeline develops. The impact on the organization is extensive due to the ability to influence disease area strategy, and the network of collaborators from preclinical research to operational, regulatory and commercial functions. Success in this role requires the ability to influence and lead at the highest possible level. The Early Neuro-Development GPH will be a critical member of the NOD leadership team and will be joining at a key point in time with the opportunity to build and influence group. This role will require the ability to innovate and think creatively, engage multiple internal and external stakeholders, and make key decisions. The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH establishes the goals for the global project team (GPT) and participates in strategic planning for, and oversight of, the clinical and research activities of his/her area of responsibility. The GPH will be delegated such responsibilities as interaction with regulatory/health authorities, approval of protocols, informed consent documents, clinical study reports and product label. In addition, the GPH will be responsible for the communication strategy and scientific disclosures and travel authorizations, expense reports, and will interact with opinion leaders and consultants. Sanofi’s Research and Development Sanofi‘s specialty care is focused on four Therapeutic Areas: Rare and Rare Blood Diseases, Neurology & Ophthalmology Development (NOD), Immunology, and Oncology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. The NOD includes programs in Multiple Sclerosis, Neuroimmunology, Neurodegeneration, and Ophthalmology, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy. Sanofi has a large internal research team in addition to the Genomic Medicine Unit (GMU), which are committed to building the future pipeline in various neurological and ophthalmological diseases. Scientific and technical Expertise Has and maintains deep scientific, technical and clinical expertise in Neurology Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders Oversees development planning, execution and budget Owns the overall program strategy and leads the international cross functional team to meet program objectives Participates in life cycle management strategy planning in collaboration with marketing teams Proposes strategies for interactions with health authorities Establishes project goals in alignment with functional resource allocation, goals and objectives Responsible for generating support and implementation of clinical studies Ensures operational plans are integrated across all functions Is responsible for annual budget deliverables . Management and Career Development Ensures that team members are adequately qualified and trained in the task they are required to perform. Including accountability and maintaining compliance training for direct reports Works cross functionally to select appropriate team members Sets team’s objectives, and works closely with direct reports to create individual performance and development goals Regulatory responsibilities Ensures clinical data meets all necessary regulatory standards Supports registrations, label submissions and modifications Manages Advisory Committee preparation and participation Scientific data dissemination Ensures timely submission and dissemination of clinical data Supports the planning of advisory board meetings Establishes and maintains appropriate collaborations with knowledge experts In addition to the above activities the GPH ensures that all activities of the GPT are conducted in compliance with current regulations, laws, and guidance from FDA, EMeA, and CHMP, as well as with Sanofi’s policies and procedures. Basic Qualifications Medical Doctor Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) More than 5 years of clinical or scientific, or more than >10 years industry, experience within the field of the specific therapeutic area compounds Fluent in English (verbal and written communication) Preferred Qualifications Strong scientific and academic background with deep understanding of disease mechanisms Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals Strong leadership skills to manage international, cross-functional teams of highly skilled individuals Good networking ability in cross-cultural environment Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization In depth knowledge of global drug development activities including the development of other health care solutions along the whole value chain from research up to market access. Skilled in project and/or budget/resource management Strategic thinking in combination with understanding science and technologies Performance oriented with ability to work along agreed timelines and a focus on strategy and execution Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into four global business units: Sanofi Genzyme, Sanofi Pasteur, General Medicines, and Consumer Healthcare. Department Description: The Digital Strategic Partnerships team is a key group within the Digital Innovation & Partnerships organization of Sanofi Digital, a global enabling function within Sanofi focused on digital growth and transformation. The mission of Digital Partnering is to seek, execute, and establish partner relationships that address the Sanofi Group’s digital strategic priorities. Partnering includes the search & assessment, evaluation, structuring, negotiation, closing, and management of strategic alliances with external companies, involving products, technologies and other product-related assets to support our digital goals. Sanofi believes digital will transform the way therapies are discovered, developed, and brought to patients, providers, and payers. Additionally, digital solutions represent new ways of improving care at a reduced cost with improving the patient & consumer experience. Partnering with digital health startups, tech companies, and others in this space is critical to drive transformation. Role Description: This position will support a portfolio of digital alliances. to ensure coordination and value creation by the different functional experts, including operational units within Sanofi and with the alliance partner. The role will oversee partnerships are on a path to realize impact consistent with the strategy, priorities and contractual obligations of the parties. The Senior Manager will be supporting the Senior Director and DSP team as needed on negotiation of new deals (or amendment of existing ones) bringing lessons from existing partnerships into new agreements. The position requires stakeholder management and leadership skills and a self-starter mentality as well as the ability to identify the needs of the business and the functions within Sanofi. The Senior Manager needs to be able to work in an amorphous environment applying a good level of business acumen, the ability to forge productive partnerships, drive cross-functional and cross-national teams towards defining and delivering results without direct reporting lines. Mission and Objectives/Key Accountabilities: The Senior Manager is responsible for developing, maintaining and optimizing strategic alliances and partnerships and will: Manage assigned Alliances providing updates to internal stakeholders on the health of the alliances throughout their existence, focusing in particular on the strategic and contractual aspects of the relationships. Monitor and oversee collaborative projects, provide quarterly updates tracking progress, timelines and performance metrics to ensure successful execution. Facilitate effective and clear communication between internal teams, alliance partners to ensure adequate flow of information and knowledge transfer. Maintain accurate records of alliance activities and agreements and ensure that information is updated in the appropriate internal systems. Assess and mitigate risks associated with assigned alliances, ensuring compliance with legal and regulatory requirements. Governance: Manage the alliance governance ensuring internal alignment of the Sanofi committee members and effective decision making of the governance bodies; ensure that the committee meetings are conducted efficiently and on a regular basis; drive key components of the meetings (e.g. objectives, agendas, and minutes). Identify changes and make adjustments and/or recommendations to the governance structure as needed to optimize the effectiveness of the alliance. Contractual Management: Ensure compliance with contractual provisions and rights jointly with Legal, Commercial Operations, Digital, IA, and R&D. Recommend necessary amendments to the contracts and participate in renegotiations process in close collaboration with Legal, Partnering and other functions. Anticipate and manage disagreements and disputes, minimize conflict, and avoid breach of contract and litigation risk. Strategy: With Senior Director of Alliances, establish and build a Digital Alliances Center of Excellence (COE) capturing digital alliance best practices and creating a community within Sanofi to share and exchange ideas With Senior Director of Alliances and Partnerships colleagues, participate in strategic research projects such as benchmarking Sanofi Digital Alliances against competitors within and outside of the industry Contribute to Digital Strategic Partnerships & Alliances cross-team projects as required QUALIFICATIONS: Education: BA/BS required; Business degree (MBA) and/or Scientific / Engineering Degree (BS, MSc, PharmD or PhD) is a plus Experience, Knowledge, and Core Competencies: Minimum of 3+ years of work experience in life sciences/health care or tech industry, minimum of 2 years in digital health space either from an investor, strategic partner, or start-up perspective Ability to organize, collaborate and lead cross-functionally with scientific, engineering, digital, data, finance, and/or commercial team members. Proven soft skills: ability to listen, interpret and respond to information that may be sensitive and material for both Sanofi and the alliance Partner. Experience in interacting in a highly professional manner with senior executives both within the parent organization and with partner companies. Knowledge of the pharmaceutical/biotech/medical device/technology industry(ies), Knowledge of new digital technologies, terminology, tech / start-up culture, product development processes (e.g. agile) or approaches, technology deployment, or data and analytics projects Highly motivated and team-oriented professional eager to face business challenges, share experiences and add sustainable value to the organization. Strong desire to pursue a career in alliance management and partnering. Advanced knowledge of MS Office applications Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Position Overview/Department Description The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support. The cell culture process development group is responsible for viral vector production optimization and development of next generation production platforms to support high dose therapeutic products. The group is seeking a motivated Senior Research Associate to join the team. Key Responsibilities: Support the execution and data analysis for viral vector production process development experiments Work with risk group 2 infectious materials, follow safe lab procedures and maintain good laboratory practices (GLPs) Contribute to technical reports and protocols Support maintenance of facility infrastructure and management of assay reagent, control and standard inventories, as well as other support requirements Collaborate with team to identify areas for improved operational excellence Stay updated on new, relevant technologies and published literature to support innovation within the group Support new technology evaluations to increase product yield and process understanding Communicate effectively with teams Display sound technical judgement Perform weekend and holiday work to support on-going lab activities Basic Qualifications: Master’s degree in biological science or engineering discipline or a Bachelor’ degree with a minimum of 2 years of experience Knowledge and understanding of cell culture and viral vector production systems Understanding of key test performance indicators, monitoring and trending of data Ability to stand and work with lab bench equipment Good organizational, record keeping, and communication skills Preferred Qualifications: Experience with cell culture techniques with strong understanding of aseptic operations Motivated and self-directed with commitment to meet aggressive timelines Ability to work on multiple tasks simultaneously Ability to work under moderate supervision and function within a collaborative/team-oriented environment Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Position Overview: The Clinical Research Director (CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases. The role requires a well-organized, strategically focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to drive and deliver on multiple operational tasks. CRDs lead the cross-functional Global Clinical Team to establish the development strategy and execute the development plan. We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts. Main responsibilities: Clinical Research Director’s core job responsibilities include: Scientific and Technical Expertise: Demonstrates and maintains deep scientific and clinical expertise in ophthalmology. Understands and keeps up to date with the pre-clinical, translational and clinical data relevant to the molecule of interest. Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders Key responsibilities: Plans global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs, Biostatistics and Health Economics); adjusts and updates the strategy according to the project progression and information available Leads clinical development including planned life cycle management (LCM) and ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations teams Implements strategies to identify, monitor and resolve clinical program/trial issues. Serves as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data. Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provides clinical input to Statistical Analysis Plans, Target Product Profile and Risk Management Plan Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project Lead the medical/clinical assessment of license-in opportunities, as needed Manage other CRDs and clinical scientists in the same program, as needed The CRD is representative for Clinical Development: at the Global Project Team in meetings with Regulatory Agencies in Steering Committees (SC) and Data Monitoring Committees (DMC) at the Benefit Risk Assessment Committee at the Submission Task Force. Basic Qualifications: Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred More than 5 years of clinical and/or clinical development experience, or more than 7 years industry experience within the field of ophthalmology and retinal diseases Fluent in English (verbal and written) Preferred Qualifications: Board certified or eligible in Ophthalmology Completion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery Strong scientific and academic background with deep understanding of retina and eye diseases Clinical research or pharmaceutical experience in ophthalmology Knowledge of drug development Good networking ability in cross-cultural environment Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization Performance oriented with ability to work along agreed timelines and a focus on strategy and execution Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    Key Account Manager-St Louis, MO WHO YOU ARE: You have a hunter mentality and are a quick learner - always seeking to be impactful with your actions, continuously improving yourself, your team, and the world around you You thrive on direct, honest, and supportive feedback and communication You are an excellent business planner and problem solver, happy to work in ambiguity to achieve your goals You are a great matrix leader and partner - extremely organized, dependable, nimble, and self-motivated with the ability to excel in a fast-paced environment You are very patient, and customer focused with passion to make a difference THE TEAM: You will be joining the National TZIELD Sales Team within the Diabetes Commercial organization and will work closely with an internal matrix team. The National Sales Team for TZIELD is an elite sales team that is launching an innovative first in class treatment for the delay of the onset of clinical Type 1 Diabetes. The focus is to clinically educate, facilitate the identification of at-risk patients through screening, and work closely with key accounts and other relevant customers to treat patients in a timely and efficient manner. KEY RESPONSIBILITIES: Expertise in clinical data, disease education, diagnostics, product information, selling skills, business analytics and market trends Develop in-depth knowledge and understanding of each identified key account including strategic goals, value drivers, key access stakeholders, relevant business metrics, and unique challenges/emerging needs Develop account plans including prioritization, integration of vertical pathways and identification of spheres of influence Develop deep understanding of contracting/ product access processes at key accounts, internal and external workflows, key stakeholders, business segment and clinical evaluation/screening models Develop and deepen strategic partnerships. Account interactions to include but are not limited to endocrinology / immunology ‘C-suite’ executives and key population health decision makers at the account Perform targeted educational engagements with top community & health system/IDN accounts Support clinical advocacy (e.g., gaining KOL endorsement) & ensure coverage on provider pathways, EMRs and/or formularies. Understand pull-through hurdles, org structures & customer ways of working to ensure cross-functional/ departmental coordination Collaborating closely with cross functional team members to identify and resolve customer needs appropriately and with a high sense of urgency Attending local, regional, and national meetings as directed Maintaining strict adherence to all legal, regulatory, ethical, administrative, and financial duties Planning, organizing, implementing, and evaluating marketing programs including lectures, patient meetings, speaker programs, dinner programs and others Achieving and exceeding assigned monthly, quarterly, and annual sales quotas REQUIREMENTS: Education B.A. / B.S. degree required; advanced degree preferred Have a valid driver’s license and willingness to travel on the job (~50% of travel given field-based role) Experience Proven track record of success in various field-based sales roles Demonstrated entrepreneurial mindset with hunter mentality A solution-oriented mindset enabling effective and creative problem solving with customers’ needs as a primary focus An outstanding communicator and networker with strong negotiating skills Promote and lead with direct, honest, and supportive communication Ability to develop organizational capabilities while influencing others Lead and inspire others when facing highly ambiguous, complex situations Eager to improve oneself, the immediate team, and the greater community Utilize effective, professional communications to cultivate strong working relationships with both internal and external colleagues; displays flexibility in your approach to people and situation L3-1 Level Up to 50% travel Pursue Progress Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. The salary range for this position is $116,156.25 to $154,875.00. In addition to sales incentive (role may my eligible for long term incentive depending on level and performance); all compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com Our people are responsible for managing their career Sanofi posts all non-executive opportunities for our people We give priority to internal candidates Managers provide constructive feedback to all internal interviewed candidates We embrace diversity to hire best talent We expect managers to encourage career moves across the whole organization A few practical tips: Be sure to regularly update your Workday profile to simplify the application process Be aware of any applicable eligibility criteria in the country to which you are applying Before applying, inform your manager so they may support your career development goals Sanofi careers - it all starts with you! Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    Position Title: Vaccines Sales Professional – Northern Minneapolis, MN Who You Are: You are a self-motivated sales professional who is equally passionate about our mission to chase the miracles of science to improve people’s lives. You understand the importance of achieving your business goals through a customer focused plan of action and being a team player by sharing your knowledge and positive energy to support team success. One of the many qualities you have is discovering your customer’s needs to align on common goals and being open to doing things differently to achieve better results. Where You Will Work: Remote- Northern Minneapolis, MN The Team: The Sanofi Pediatric Sales Team is responsible for the promotion and sales of vaccines for children and adolescents. We are a team of sales professionals, passionate in our commitment to prevent deaths from preventable diseases and to our customers and their patients. We share a culture of company and employee commitment where we value the talent of our team members and the achievement of our business goals. Job Highlights: The Vaccines Sales Professional (VS) is responsible for achieving/exceeding annual territory sales quotas across a diverse customer base within both public and private sectors (e.g. Physician Offices & Medical Groups, Integrated Health Networks, State Departments of Health, Vaccine for Children’s program, Federally Qualified Health Centers). The VS will engage customers through virtual and face to face interactions, achieving the optimal reach, frequency, and outcomes through appropriate planning and call implementation. The VS is required to develop and maintain expertise in disease and product knowledge, utilization of business data, business planning and organization, customer engagement and selling skills, team collaboration, technical skills, and territory administration. The VS is expected to have a thorough understanding of the national brand strategy, brand messaging and resources to effectively implement specific account action plans based upon their unique marketplace. The VS is required to develop a strategic partnership with his/her customers using the Sanofi Pasteur sales model to uncover customer business needs and identify product/non-product opportunities to address their needs. VS is responsible for embracing team selling by communicating, collaborating, and orchestrating with other appropriate field and home office team members to ensure an aligned Sanofi Pasteur approach to customers. Basic Qualifications: Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four-year college or university (or the equivalent if education obtained outside of the United States) 2 years of pharmaceutical, business to business sales and/or medical experience Other pharmaceutical experience where individuals have demonstrated the ability to influence others may be considered (marketing, operations etc.) Preferred Qualifications: Candidates who reside within the territory or a commutable distance The Fine Print: Candidate possesses a valid driver’s license and a record of safe driving according to Sanofi policy. Candidate is able to provide 2 years of performance review documentation. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
  1. Sanofi

    Audit Manager - Cambridge

    • Full Time
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    At Sanofi, we are united by one purpose: we chase the miracles of science to improve people’s lives; and one strategy: Play to Win. We are focusing on growth and portfolio prioritization, bringing transformative therapies to patients, accelerating efficiency, creating a culture where everyone is in position to play to win and can bring the best of their whole self to work. Reporting to the Chief Executive Officer and the Audit Committee, the mission of Sanofi Internal Audit (SIA) to provide independent and objective reasonable assurance regarding the group’s ability to control its operations according to the Institute of Internal Audit (IIA) international standards. The Department is organized around 6 areas of expertise: Global Business Units (Specialty Care, General Medicines, CHC and Vaccines), R&D, Industrial Affairs, Corporate Functions, Asia and China, and Information Systems, and is supported by Audit Operations and Digital transformation activities. Based primarily in three locations: US (Cambridge and Bridgewater), France (Paris) and Singapore, our people work on transversal assignments for all activities and functions and contribute to projects that span the globe. Additionally, to best serve our APAC region, we’re currently evolving our presence, by adding a fourth location in Shanghai (China). With a strong focus on integrity, objectivity, confidentiality, and the competency of our people, we ensure that: We recruit and develop our professional audit staff, with the right knowledge, skills, and certifications, allowing them to complete Audit Plans with high quality standards. We maintain the highest level of expertise and audit proficiency. And we do our work in accordance with the Institute of Internal Auditors (IIA) standards. Role Summary We handle all auditing activities, including: Executing the yearly Audit Plan and ensuring it progresses against agreed milestones and identified risks. Running the internal audit assignments, including drafting the final reports, based on which Sanofi executive management defines action plans to remediate findings. Monitoring the progress of management’s action plans, to ensure that audit findings are addressed, and the associated risks are appropriately mitigated. As part of our team, you will: Work in a truly international environment, sharing your expertise with fellow Sanofians, and mastering the full spectrum of auditing activities, including culture check-up. Be exposed to, and gain insights into each phase of the product lifecycle, from the initial Research & Development (R&D) efforts, through the Manufacturing & Supply (M&S) and commercialization of our products across 4 different Global Business Units (GBUs). Support the evolution and transformation of the organization, including corporate and digital functions. A trusted business partner, our team fosters a Risk Management Culture within Sanofi and drives changes within Sanofi processes, governance, and culture. Main Responsibilities Work collaboratively with audit teams to perform planned operational, compliance and integrated audits across different functions and sites Conduct planning activities to identify relevant risks and develop appropriate risk-based audit procedures Interview key personnel to assess business processes and the strength of their control environments Lead meetings involving various levels of management to effectively communicate audit status, align on significant audit issues and recommended corrective actions Coordinate the day-to-day activities of audits and auditees interactions, ensuring efficient information flow from your auditees to the audit team Prepare clear, detailed audit documentation evidencing the results of actual testing procedures in accordance with Sanofi Internal Audit and the Institute of Internal Auditors (IIA) standards. Prepare audit reports, including clearly written recommendations that effectively communicate identified issues and their related corrective actions to help auditees and senior management strengthen and improve operations, including opportunities (as appropriate) for cost savings or efficiency gains Demonstrate and maintain working knowledge and staying current on developments in audit literature' including those specific to our industry Participate in and take on additional departmental projects as assigned (e.g., audit lessons learned, training, continuous improvement, etc.). About you Education and Work Experience A BA/BS or advanced degree Minimum of 5+ years prior public accounting or internal/external audit experience, internal control, business support Finance, including experience in managing financial, operational or compliance audits preferably in a large, multinational publicly traded company. Alternatively, minimum 5+ years working experience in a pharma company in a commercial, marketing, business operations and support, manufacturing, supply chain, medical or R&D role and willing to discover internal audit. Knowledge of IIA standards is preferred but not required SAP knowledge would be an asset Strong knowledge of Excel/Word/PowerPoint Data Analytics experience (specifically with visualization tools such as PowerBI, QlikView, and Tableau) is preferred but not mandatory Excellent spoken and written English is essential International exposure and/ or experience working with a diverse team preferred. Experience in pharmaceutical/ healthcare industry is or life-sciences business acumen (R&D, Medical, Industrial Affairs, Market Access etc.) is preferred but not mandatory Professional Skills and Attributes Ability to work transversally and within a highly matrix environment. Self-driven and proactive with a willing attitude to learn and patience to guide inexperienced team members. Inquisitive and persuasive with a global mindset and able to recognize and respond to diverse thinking styles, learning styles and cultural sensitivities. Demonstrated ability to interact with and influence senior level stakeholders Strong project management and communication skills. Effective in prioritizing work and following through on commitments. Maintain the highest standards of ethics and integrity as well as respect for confidentiality of sensitive matters. Operate with a collaborative mindset. Acute attention to detail with strong qualitative and quantitative analytical skills. Ability to take large volumes of complex data and/ or information and present it in a clear and concise manner. Strong analytics skills with the ability to collect, organize, analyze, and disseminate information with attention to detail and accuracy Strong verbal and written communication skills Ability to travel approximately 30% of the time, including international travel for up to three weeks at a time Why Join Us? If you’re looking for place to get exposure to a complex, dynamic business and grow your career, then this is the team for you. The work you’ll do has a real impact on the business and organization. You’ll be directly contributing to Sanofi’s ability to execute its strategy and achieve its business goals and ambition to transform the practice of medicine. By joining us, you’ll get the best of both worlds: expand your auditing skills and career, while getting to know a diverse pharma business, that will allow you to grow your career all the way up to managerial or Subject Matter Expert roles. This role is an exceptional training ground for future executives, which also provides unique opportunities to: Learn the different activities of Sanofi and the pharmaceutical business environment Gain exposure to diverse audit assignments, ranging from Commercial Operations, Manufacturing and Supply to specific thematic audits (i.e., 3rd party management, R&D, Digital, Sales Force Management, Culture Review, etc.) Increased visibility and network across different stakeholders, including senior management and executives Work in a multi-cultural team environment and identify value-added recommendations to drive business process change Acquire project and team management skills Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    The gene therapy development and manufacturing group in Sanofi is responsible for the design and optimization of viral vector manufacturing processes and platforms. A key function of this group is to establish operational excellence in the manufacturing of gene therapy materials and products, through the development and implementation of robust and safe manufacturing practices, capable of supporting program needs, that are aligned with Sanofi internal standards and evolving regulatory expectations The manufacturing operations team is responsible for the safe and compliant execution of established manufacturing procedures to meet aggressive program deliverables. The team is responsible for “transfer-in” of manufacturing operations from development, as well as manufacturing of product to support internal program needs and external technology transfers for early and late-stage clinical gene therapy products. The Senior Research Associate will be responsible for executing upstream and operations under control of established manufacturing procedures and cross training of junior staff as needed. KEY ACCOUNTABILITIES Independently execute established procedures with accountability to accuracy and control of operational performance with a strong focus on aseptic technique, biological control, process safety and documentation practices Adherence to production schedules to ensure commitment to meet aggressive timelines and deliverables Collaborate with process development to identify areas of improvement and identify suitable solutions for improved process performance and control, as needed Support incoming and outgoing process transfers consistent with internal and external transfer procedures, working closely with customers and end users Independently, manage personal training schedules as per established procedures and other group policies supporting process control and safe operations Support process investigations to address process excursions or out of expectation results, identifying root cause and corrective action plans and monitoring for correction Provide self-awareness and real time analysis of operations to anticipate potential unexpected process outcomes, working collaboratively with team to resolve or find suitable solutions Perform process analyses, contribute to technical reports, protocols and internal/external presentations as needed Provide support on maintaining facility infrastructure and all process support activities Attendance at Gene Therapy Technical Operations at inter-departmental meetings and work streams as needed Stay updated on new, relevant technologies and published literature to drive innovation within the group Occasional weekend and holiday work to support ongoing lab activities BASIC QUALIFICATIONS BS in biology or a related discipline with 2+ years of relevant experience or a MS in a related discipline Knowledge and practical experience in upstream manufacturing operations; including but not limited to adherent and suspension cell culture, cell count technologies, disposable bioreactors, depth filtration/clarification, ATF/TFF perfusion technologies Practical experience in aseptic technique in a variety of cell line maintenance techniques Relevant experience in troubleshooting process excursions, performing investigations and identifying appropriate solutions PREFERRED QUALIFICATIONS Experience with Gene Therapy manufacturing platforms including cell banking, viral banking and drug substance generation Experience and knowledge of working with risk group 2 infectious materials Experience performing process transfers, either to external third party vendors or internal transfers from outside parties is a plus Experience in technical writing preferred Self-directed and motivated individual and commitment to meet aggressive timelines Excellent organization and written skills, committed to internal documentation practices Ability to work on multiple tasks simultaneously Able to work under moderate supervision and function within a collaborative/team oriented environment Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency Mentoring junior staff for training and understanding of process performance Ability to communicate and represent group in meetings cGMP experience or support a plus Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    Job Description Cell Culture Development within the Mammalian Platform organization is responsible for the development of cell line and cell culture technologies and processes that support all phases of CMC from pre-candidate selection through BLA. As a member of the Cell Culture Development leadership team, this leader will lead and manage the U.S. based group to develop commercial upstream processes for pivotal trials and commercial launches. This team will focus on developing high productivity fed-batch and perfusion processes through medium/feed optimization and process intensification leveraging the cell culture platform. The leader will be responsible for successful process scale-up and transfer ensuring good facility fit across our commercial network. Process characterization, validation and IND/BLA authorship are also part of the commercial development responsibilities. The leader will be a key driver of cell culture innovation with clear line of sight to commercial implementation. The position will require close collaboration with the cell culture platform group, cell line development, purification, tech transfer, and clinical and commercial manufacturing. It will have wide-ranging discretion and independence in driving the commercialization strategy and modernizing our approach for efficiency. Duties and Responsibilities Develop industry-leading high performing commercial cell culture and harvest processes Ensure highly scalable and robust commercial processes Drive for product quality attribute understanding and control to meet comparability Deliver thorough process characterization packages using the latest advances in DOE statistical tools, multivariate analysis models and prior knowledge strategy Drive strategy for process validation Responsible for upstream CMC activities ensuring successful IND and BLA submissions Drive technology and organizational development initiatives that improve cost and efficiency Collaborate cross-functionally to develop and improve commercialization business processes Develop and manage department goals and budget in line with the broader objectives of the Cell Culture Development and Mammalian Platform organizations Provide scientific strategy and guidance to staffs. Manage their development and build strong, high-performing teams Actively publish and present externally. Pursue IP opportunities for the company. Basic Qualifications Degree in chemical/biochemical engineering, bioengineering or relevant discipline BS/MS with 15+ years of relevant professional experience, OR PhD with 10+ years of relevant professional experience Required Skills Proven experience in developing cell culture and harvest processes for clinical and commercial manufacturing Strong CMC experience covering all aspects of development from FIH to commercial process development, process characterization, and regulatory submissions Previous leadership experience in successfully managing and developing scientific staffs Thorough working knowledge of GMP manufacturing with understanding of equipment and process validation Proven skills in building and maintaining productive relationships with cross-functional partners such as manufacturing, quality, supply chain and regulatory In-depth knowledge of medium development, bioreactor scale-up principles, scale-down models, tech transfer concepts, and bioreactor engineering Working knowledge of high-throughput cell culture and automation technologies, process monitoring and control, process modeling and DOE statistics Strong background in CHO cell metabolism, glycosylation and product quality attribute control Proven track record of innovation demonstrated by a consistent record of external presentations and publications Ability to effectively translate innovation into business value that benefits the pipeline and manufacturing Ability to lead effectively in a matrix organization Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    Quality Assurance Specialist–Genomics Medicine Unit Framingham, MA Job Description: This position will report to the Associate Director of Quality and will assist in maintaining the quality systems and GMP compliance in support of cell and gene therapy products at Sanofi. This is a second shift position 12 PM to 10:30 PM Friday through Monday Perform review of Batch records and associated documents in support of release of intermediates. Review of Analytical data Participate or lead in investigation of all lot-associated deviations, change controls, Environmental Management System (EMS) investigations, action notices and environmental excursions as required. Perform QA presence on the floor/person in plant Perform various QMS trending/reporting functions. Ensure compliance to the relevant SOP and corporate standards. Lead/Participate in investigation of non-lot associated deviations, change controls (CCR/LCR), Building Participate in walkthrough program. Manage assigned site QA projects. Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies. Draft and revise procedures (DCR) as required. Serve as an internal auditor for the site. Actively participate in the preparation, execution and follow-up for audits from Global Quality Auditors. Participate or facilitate FMEA/Risk as appropriate. May serve as team leader for continuous improvement teams or investigative teams. Investigate quality critical alarms. Assist in the development of Quality Technical Agreements (QTA). Performs work that requires decision making and the consistent exercise of independent judgment and discretion. Perform Quality Assurance review for deviations, investigations, DCRs and complaints and manage associated files. Review and approve Validation protocols and technical reports as appropriate. Assist in the oversight of the sterility assurance program. Perform, External audits Education Master's Degree & 3 years of experience OR Bachelor's Degree & 5 years of experience in cGMP. Ideally the candidate will have a degree in Microbiology Preferred Qualifications: Excellent communications skills both written and verbal. Strong knowledge in aseptic technique, practices and theory. Strong Knowledge of Contamination Control Experience in Cell and Gene Therapy Strong critical thinking ability. Strong leadership ability. Effective time management and organizational skills. Strong attention to detail and ability to lead others in a team setting. Experience with CDMOs Special Working Conditions Ability to gown and enter clean rooms Ability to perform visual inspection for final product May require up to 15% of travel (Domestic and international) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    Quality Assurance Specialist - Framingham, MA This is a second shift position 12 PM to 10:30 PM Friday through Monday Job Description: This position will report to the Associate Director of Quality and will assist in maintaining the quality systems and GMP compliance in support of cell and gene therapy products at Sanofi. Perform review of Batch records and associated documents in support of release of intermediates. Review of Analytical data Participate or lead in investigation of all lot-associated deviations, change controls, Environmental Management System (EMS) investigations, action notices and environmental excursions as required. Perform QA presence on the floor/person in plant Perform various QMS trending/reporting functions. Ensure compliance to the relevant SOP and corporate standards. Lead/Participate in investigation of non-lot associated deviations, change controls (CCR/LCR), Building Participate in walkthrough program. Manage assigned site QA projects. Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies. Draft and revise procedures (DCR) as required. Serve as an internal auditor for the site. Actively participate in the preparation, execution and follow-up for audits from Global Quality Auditors. Participate or facilitate FMEA/Risk as appropriate. May serve as team leader for continuous improvement teams or investigative teams. Investigate quality critical alarms. Assist in the development of Quality Technical Agreements (QTA). Performs work that requires decision making and the consistent exercise of independent judgment and discretion. Perform Quality Assurance review for deviations, investigations, DCRs and complaints and manage associated files. Review and approve Validation protocols and technical reports as appropriate. Assist in the oversight of the sterility assurance program. Perform, External audits Education Master's Degree & 3 years of experience OR Bachelor's Degree & 3 years of experience in cGMP. Ideally the candidate will have a degree in Microbiology Preferred Qualifications: Excellent communications skills both written and verbal. Strong knowledge in aseptic technique, practices and theory. Strong Knowledge of Contamination Control Experience in Cell and Gene Therapy Strong critical thinking ability. Strong leadership ability. Effective time management and organizational skills. Strong attention to detail and ability to lead others in a team setting. Experience with CDMOs Special Working Conditions Ability to gown and enter clean rooms Ability to perform visual inspection for final product May require up to 15% of travel (Domestic and international) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
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    About the Job Sanofi is a leading bio-pharmaceutical company committed to advancing healthcare through groundbreaking research and development. The Clinical Innovation team at Sanofi is responsible for identifying, accelerating, and scaling innovations that can serve to improve operations and/or outcomes for patients, sites, and sponsors of clinical trials. The Clinical Innovation team includes our digital biomarker strategy and operations team which focuses on establishing and executing digital biomarker programs that generate health-related data through digital health technologies (DHTs), provide valuable insights into patients' conditions, and aid in improving the clinical trial experience. This role will focus on utilizing DHTs and related data to create digital endpoints in clinical trials, ensuring accurate evaluation of treatment outcomes, and advancing Sanofi's scientific understanding of disease. As we continue to drive excellence and innovation in our clinical trials, we are seeking an exceptional professional to join us as a Clinical Strategy Lead for Digital Endpoints . Job Overview: The Clinical Strategy lead for Digital Endpoints drives and augments Sanofi’s success in R&D by defining and executing innovative digital biomarker strategies across our R&D portfolio. The role is responsible for end-to-end integration with clinical studies, and the role identifies, creates, validates, and operationalizes both fit-for-purpose and novel digital endpoints in Sanofi’s clinical studies. Collaborating across teams, the role ensures seamless integration of therapeutic area needs with cutting-edge technologies, delivering impactful solutions to patients and enhancing our clinical programs. Additionally, the role will contribute to identifying, testing, and adopting new technologies that show promise for clinical digital measurement and growing Sanofi’s digital biomarker expertise and thought leadership. Key Responsibilities: Digital Endpoint Strategy Development and Execution: Identify opportunities for digital endpoint/outcomes strategies in collaboration with clinical teams to integrate novel and fit for purpose digital measures into clinical studies. The role will work closely with the therapeutic area teams to understand the strategic needs across Sanofi’s portfolio, and the role will be responsible for establishing and understanding the DHTs available to create value for patients, programs, and operations. The role will also communicate the respective value and potential of the available DHTs to clinical and development teams throughout all stages of an R&D program.Lead cross-functional teams in creating integrated plans to develop, validate, and deploy digital endpoints. The role will be responsible for recommending digital endpoints and driving the cross-functional teams to select or design the respective DHT both to address meaningful aspects of health and to add value to Sanofi’s development portfolio.Operationalize digital endpoint strategy programs and serve as the primary point of contact, organize and manage multi-workstream efforts to meet strategic goals. The role will be responsible for creating and executing the integrated validation and testing plans to support strategic study timelines and goals. Additionally, the role will create and implement KPIs, and communication strategies to inform leardership of milestones, and results. The role will work closely with the Digital Biomarker Operational Leads to ensure the operational needs for each study are defined, communicated, and executed.Integrate essential inputs such as health authority feedback, legal, intellectual property, data use, and privacy considerations into the Digital Endpoint strategy to ensure feasibility. Revise and communicate strategic and operational plans when appropriate while ensuring the patients’ needs are at the core of the deliverables.External representation: Represent Sanofi Clinical Innovation internally and externally to the biopharma and digital biomarker communities. Communicate the potential and value of digital biomarkers, educate about the processes and considerations when incorporating digital endpoints into programs and studies, and recommend opportunities for innovation.Drive the Clinical Innovation team forward: Contribute to the growth of the digital biomarker organization, identify unmet needs within the organization with respect to process and strategy, propose and execute solutions. Collaborate to deliver agile and effective change management. As an expert, remain up to date on the internal digital endpoints portfolio, on current and emerging technologies, industry milestones, and regulatory impacts.Matrixed Leadership and Change Management: Effectively lead innovation and transformation projects within the department, and in collaboration with other teams, fostering a culture of innovation, collaboration, and continuous learning.Stakeholder Collaboration: Collaborate with and lead cross-functional teams, including but not limited to Clinical Research Directors, Regulatory Affairs, Clinical operations, Research, Digital, Medical Affairs, and Health Economics and Value and Access to align digital measurement innovation efforts with overall business goals.Performance Metrics: Define key performance indicators (KPIs) and establish metrics to measure the success of innovation and transformation initiatives. Regularly report progress to senior management. About You Qualifications and Experience: Degree(s) and/or a combination of 10+years relevant experience in life sciences, pharmaceuticals, or a related field, clinical data analysis, clinical outcomes assessments, and/or digital health technologies contributing to a solid grasp of the intersection of clinical development and digital health technologies.Strong knowledge of digital health technologies and/or digital measurements in clinical trials and regulated settings. Foundational understanding and working knowledge of diseases, symptomology, and relevant assessments such as clinical outcomes assessments and/or patient reported outcomes.Proven track record of driving innovation and executing complex cross-functional digital projects, identifying opportunities and leading teams to new adopting new technology solutions.Basic knowledge in data and data science, data management, diseases area, R&D organizations in biopharma, USA and EU health authorities, user experience and user acceptance testing.Excellent leadership and stakeholder management skills, with experience in a matrixed environmentDemonstrated ability to think strategically, identify opportunities, and implement effective solutions.Exceptional communication and interpersonal skills, capable of collaborating with stakeholders at all levels of the organization. Excel at storytelling and integrating complex, multi-disciplinary workstreams to present recommended actions.Demonstrated ability to manage multiple projects simultaneously and work effectively under tight timelines.Education: Bachelors required, Advanced degree in relevant subject matters is preferredLanguages: Fluency in spoken and written English requiredLocation: Cambridge, MA USA If you are a visionary leader with a passion for transforming patient care using digital health technology and driving innovation in pharmaceutical clinical trials, we encourage you to apply for this exciting opportunity. Join our team and contribute to our mission of improving patient outcomes through cutting-edge therapies. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for a clinical development program, reporting into the Global Project Head (GPH), and managing a team of Clinical Research Directors and Clinical scientists. The role requires a well-organized, experienced, strategic focused and resourceful individual with interpersonal skills, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks. The anti-TL1A program is a co-development with TEVA, with a primary focus in inflammatory bowel diseases and with planned indication expansion in immune driven and fibrotic diseases. The role of the Senior CRD is to: Lead the clinical development plan strategies and implementation Lead/Act as a mentor for other CRDs and Clinical Scientists on a same project/TA Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). Within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. Lead clinical activities: Provide clinical expertise Support study related clinical activities, e.g. protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment Oversee and contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Coordinate with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps Key responsibilities include: Clinical development plan strategies: Clinical strategy: Develop and assess clinical scenarios in alignment with Global Project Head Internal Governance: Preparation of documents and presentations for internal governance meetings Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams Contribute to the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Engage and collaborate with internal and external partners, regulators, and experts Execution of clinical development and studies activities Lead study implementation and remediate study issues Review and validate the clinical study report and key results memos Oversee and is accountable for study related clinical activities Develop the abbreviated protocol Review and validate the final protocol, protocol amendments and study supporting documents Co-Develop the SAP in collaboration with bio stats Responsible for key results preparation and clinical study report Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs) Medical support to clinical operation team during the clinical feasibility Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO Lead the study specific committees (IDMC, steering com, adjudication …) with operational support Answer to medical questions raised by EC/IRBs, sites Contribution to regulatory and safety documents and meetings: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project. Oversee and is accountable for clinical input in key regulatory documents: Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP. Supports registrations, label submissions and modifications: Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Clinical expertise, scientific data evaluation and authorship: Act as a TA level expert/referent in the field of inflammatory bowel diseases. Evaluates relevant medical literature and status from competitive products Support the planning of and participates to advisory board meetings Participate and author manuscripts and abstracts Establish and maintains appropriate collaborations with knowledge experts Experience Clinical development in the field of immune driven disease and ideally in inflammatory bowel disease Understanding of pharmaceutical product development and life cycle management gained through ~5 years of development and medical experience Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies Ability to influence and negotiate to ensure operational resources are available for continued clinical conduct Strategic leadership and understanding of the drug development value chain Excellent teaching skills, demonstrated ability to assist and train others Ability to work within a matrix model International/ intercultural working skills Open-minded to apply new digital solutions Minimum Level of any Required Qualifications: Medical Doctor (MD): Gastroenterologist and/or experience in internal medicine and immune driven diseases Fluency in written and spoken English Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers. We are looking for: Global Value & Access Pompe Specialist- VIE Contract (W/M) Target start date: 01/12/2023 Responsibilities: Support market access leads in country engagements with additional analysis and logistics coordinationPartner with affiliate market teams in the development of price dossiers and prepare for launch by refining market access and pricing strategies through collaboration with Health Economics and Values Assessment (HEVA) colleagues to support payer needsTrack upcoming competitive entry expected to gain regulatory approval. Track and effectively communicate/present know regulatory approvals and submission, reimbursement decisions, price publications, discounts, and market level activities for the competitionUpdate and maintain resources for markets (updating Market Access Value Platform (MAVP), Teams, SharePoint etc.Set the agenda for biweekly team meeting & track key deliverables (all net price approvals, price / patient, key issues, etc.Monitor the marketplace for access issues, threats & opportunities, particularly regarding rare diseases, and perform thorough research as appropriate, and prepare analog assessmentsAssist on an ad-hoc basis with strategic market access projects and presentations Requirements: Master’s degree in Market Access and/or Health Economics, / MBA / ScienceUnderstanding of pricing & reimbursement processes in at least one key European market will be an assetKnowledge of market access specifics for rare disease therapies a plusExperience supporting the development of an HTA (Health Technology Assessment) dossier for a rare disease will be beneficialGood knowledge of MS Office SuiteFluent EnglishAbility to plan/organize the work & tasks and to work within tight timelinesStrong sense of responsibilityDemonstrates positive attitude, proactive, embraces team spirit and comfortable with dynamic environmentDemonstrated relationship building at all levels of the organization and across geographiesExhibits outstanding written and oral communication skillsQuick learner who can synthesize information and come up with creative solutions At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Reference No. R2719829 Position Title: Global Safety Officer Department: Therapeutic Area Dengue, Endemics & Travelers Vaccines, Covid Location: Toronto, Ontario Sanofi Vaccines Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. Position Summary: The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk profiles of our therapies, so we can best serve patients, care givers and health care professionals. Global Safety Officers (GSOs) are part of an international, dynamic, and culturally diverse team. Our GSOs provide medical-safety expertise based on deep knowledge of the therapeutic landscape and up to date methodologies. The GSO is responsible for performing core pharmacovigilance activities, in partnership with GPV colleagues and cross-functional experts, to evaluate benefit-risk profiles throughout the lifecycle of a broad range of marketed products and innovative therapies in clinical development. Key Responsibilities: Leads cross-functional Safety Management Teams (SMT), PV contribution for Benefit Risk Assessment Committees (BRAC), and periodic safety reports for accuracy, completeness, quality, and timely finalization for assigned products. Represents PV positions within Global Project Teams (GPT), Safety Management Committees (SMC) and Benefit Risk Assessment Committees (BRAC). Contributes to continuous improvement and refinement of methodologies, processes, and to audits and inspections. Provides safety evaluations and responses to safety inquiries from stakeholders (e.g. health authorities, business partners, etc.). Collaborates with colleagues mainly from PSPV as well as Pre-Clinical & Clinical Development, Regulatory Affairs, Medical Affairs, Legal and Global Business Units. Provides safety expertise, disease and patient knowledge for assigned products in terms of benefit-risk assessments, and risk management (incl. risk minimization measures. Key Requirements: Medical Doctor, preferably board-certified specialist in relevant therapeutic areas. Alternatively advanced health care discipline degree (PharmD, PhD, etc.) specialized in relevant areas in the pharmaceutical industry. Clinical experience in relevant therapeutic areas (in hospital settings is a plus). In-depth experience of pharmacovigilance and risk management, understanding of drug development and regulatory guidelines. Expertise in signal detection / evaluation methodologies related to drug safety information throughout the product life cycle. Applying biostatistical and pharmacoepidemiological science in the context of pharmacovigilance. Strong team player who is able to collaborate in a cross-functional environment. Self–motivated, able to prioritize and plan work independently. Good communicator with attention to detail while seeing the big picture. Open to learn and to use digital and innovative solutions in a changing environment. Strong analytical thinking incl. evaluation, interpretation and synthesis of scientific data. Ability to summarize, critically discuss key findings from safety data in both internal and external discussions. Full professional English language proficiency. Pursue Progress. Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address. At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers. We are looking for a candidate for a VIE mission of: APU Finance Business Partner - VIE Contract (W/M) Target start date: 1/02/2024 The APU Finance Business Partner monitors the overall financial operational performance of a designated APU (Autonomous Production Unit) within the Mass BioCampus (Framingham & Northborough in Boston Area). He/she contributes to the site's financial performance by providing accurate, effective & reliable financial information and improvement opportunities. The role reports to the Head of Finance, IA Boston Hub. Responsibilities: Active member of the APU Leadership Team, participate to daily +QDCI (Quality Delivery Cost and Involvement) meetings, support decision making through strong business partnering.Support and challenge the operational team by using financial results to identify levers to meet or beat site performance targets.Present financial forecast T0/T1/T2/Budget/Quarter Landing. Support RDOI (Rare Disease and Other Immunology) cluster on Strat Plan assumptions.Prepare and participate in business reviews with RDOI cluster heads (including risk assessment).Interact with other functions such as Manufacturing Excellence, Supply Chain, MSAT as well as Drug Product site.Ensure the quality and accuracy of business cases in support of project authorization requests.Challenge volumes and inventories assumptions provided by Supply Chain.COGS (Cost of goods sold) modeling per financial calendar requirements. Requirements:Master’s degree in Corporate Finance (Controlling preferred) required.Full English proficiency (TOEIC >750).Experience demonstrating strong analytical, communication, and collaboration skills.Hands-on experience with budgeting and risk management.Excellent knowledge of data analysis and forecasting models.Demonstrated skill in transversal coordination with partners and stakeholders in activities.Proficiency in ERP systems.Solid analytical and decision-making skills. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Our Team: The Associate Director, Field Execution is responsible for overseeing the execution and delivery of strategic deliverables in Field Design & Deployment, Incentives and Execution adherence in the US Market. This is a critical role with ambition to continuously innovate to drive growth and execution for all US businesses. The successful candidate will align and collaborate with all BOS Functional Leaders, other cross-functional support functions, Business Unit and Sales Leaders to ensure excellence in execution. In addition, the candidate will be identifying business efficiencies and developing innovative solutions to address market, industry, and brand opportunities based on modern industry benchmarks & customer engagement models. The Associate Director, Field Execution will report to the Senior Director, Field Execution with strong accountability to the Business Unit General Manager and Sales Leadership. Main responsibilities: Lead the strategy, design, deployment and execution of brand sales architecture, IC plans & contests and execution adherence. Align and accelerate key Therapeutic Area business drivers as set by the business. Specifically, responsibilities of the candidate will be leading are the management of field force architecture; incentives design, optimization & deployment; measurement of field execution & systems adherence using knowledge of modern industry go to market and customer engagement models. Maintain run state of these activities linked to normal weekly, monthly & quarterly processes. Coordination & support of Sales Operations activities including Quarterly Business Activities, Veeva enhancements, data/reporting enhancements, Field triggers, etc. Create opportunities for efficiencies in brand performance through process improvements, vendor leverage and data analysis, partnering with the brands to implement solutions and track ROI. Recommend changes and make suggestions to BOS and Business Unit teams using Insights and Operational expertise to drive increased performance. Collaborate with colleagues in similar roles, cross-business unit to ensure best practice sharing, drive consistency and efficiencies, and effective leverage of support teams. About you 5+ years of experience in Biotechnology or Pharmaceuticals; Undergraduate degree, MBA preferred. High emotional intelligence, change management, communication & financial acumen is required. Demonstrated ability to drive change as a forward thinker within an organization, cultivating support and maximizing contribution from other cross functional team members. Knowledge of modern Go-to-Market models, customer engagement processes and KPIs, tactics including Account vs HCP selling models, KAM & GPO strategies, hybrid selling, rep & home office orchestration, etc. Knowledge of modern incentive compensation plans across therapeutic areas; Lead vs Lag indicators, execution adherence integration, etc. Knowledge of industry standard data sets (IQVIA Xponent & DDD, 867, de-identified SP/HUB data, etc.), systems (Veeva, Salesforce, Snowflake, PowerBI, etc.) and stays abreast of modern technologies, methodologies, and their applications. Acts with integrity and adheres to excellence in governance practices Experience leading without authority in a matrix environment. Excellent presentation skills, ability to tell a story supported by facts. Excellent Project/Program management capabilities. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Reference No. R2711659 Position Title: Test & Automation Lead - Patient Services Department: Patient Engagement Delivery Location: Bridgewater, NJ Position Overview: The iCare Program is a multi-year transformational program with the objective of creating a Best-in-Class Patient-Centric ecosystem to support Sanofi Patients and Therapies. The Test & Automation Lead - Patient Services, iCare is accountable for the iCare Digital Healthcare platform testing strategy, tools/automation, and successful execution of release testing across multiple products and integration vendors. Mandate The Test & Automation Lead will be responsible for leading and managing the testing and automation efforts for Sanofi Patient Services. This role will work closely with cross-functional teams, including internal / external stakeholders, and project managers to ensure the timely delivery of high-quality software products. This role will involve planning, coordinating, and managing various testing strategies, managing testing team resources, and ensuring adherence to quality standards and best practices. The Test & Automation Lead will provide support for defining testing strategies for highly complex business processes, regulatory (HIPAA, Data Privacy, GxP, etc.), compliance and cybersecurity processes. This role will leverage the Digital portfolio, catalog of services, existing platforms as well as integrate new industry standards to define and implement the Patient Services products and services. Key Responsibilities Lead and manage the Test & Automation efforts, providing guidance, best practices, and mentoring.Acts as Authority and subject matter expert owing standards and practices related to Patient Services.Develop and implement the overall test strategy, test plans, and test cases for the Patient Services Ecosystem software products (Salesforce Health Cloud, Informatica Cloud & AWS, Salesforce & Veeva CRM, Salesforce Marketing Cloud and Snowflake)Collaborate with internal and external stakeholders to define testing requirements, priorities, and deliverables aligning to program roadmap and timelines.Coordinate with development teams to understand test design, implementation, and execution details.Ensure that appropriate testing methodologies and tools are utilized throughout the testing process.Conduct risk analysis and develop mitigation plans to minimize potential issues during testing.Monitor and track defects, ensuring they are properly reported, tracked, and resolved.Manage test environments, including test data and test infrastructure.Provide regular progress reports and metrics to project stakeholders.Continuously improve testing processes and methodologies based on industry best practices/solutions for Patient Support Program.Work as part of the Agile Team.Work closely with external vendors to align program communications, testing timelines, and coordination of testing efforts.Lead collaboratively, working with other areas within Digital to ensure that all solutions are complete, operable, conform to business processes, and meet the business needs with the agreed quality of service.Implement (and create) standards, guidelines, and processes to ensure product quality; drive product, project knowledge back to the enterprise team and ensure that it evolves correctly.Evaluate and recommend emerging technologies for iCare Testing & Automation testing team resources.Responsible for ensuring the integrity and privacy of Personal Identifiable Information (PII) and Protected Health Information (PHI).Mentor and provide guidance to iCare Test & Automation team members regarding best practices and techniques. Job-specific Skills & Competencies Proficiency Life Sciences/Patient Support Services expertise - AdvancedTesting, Automated Testing - AdvancedCompliance of computerized systems - AdvancedAgile practices - IntermediateSalesforce Technologies - AdvancedVeeva Technologies - IntermediateIntegration Technologies (IICS, AWS, Python) - IntermediateSnowflake and/or Datawarehouse Technologies - Intermediate Job Qualifications Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent experience).10+ years of experience in Software Quality Assurance (including Test Automation).Experience with life sciences/pharma.In-depth knowledge of software testing methodologies, automated testing tools, and best practices.Familiarity with different types of testing, such as functional, regression, performance, automation, and security testing.Experience with test management tools and defect tracking systems.Excellent communication and interpersonal skills.Strong analytical and problem-solving abilities.Ability to work effectively in a fast-paced, dynamic environment.Certification in software testing is a plus.Preferred experience with GxP, HIPAA and GDPR regulations. NOTE: Internal applicants are required to notify their manager of their application. Grade: Level 4 If you want to learn more about compensation grades, please go to our grade guide via the following link: https://sanofi.sharepoint.com/sites/ST_hr/SitePages/what-is-sanofi-global-grading-and-how-does-it-work-.aspx Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career. Our people are responsible for managing their career Sanofi posts all non-executive opportunities for our people We give priority to internal candidates Managers provide constructive feedback to all internal interviewed candidates We embrace diversity to hire best talent We expect managers to encourage career moves across the whole organization A few practical tips: Be sure to regularly update your Workday profile to simplify the application process Be aware of any applicable eligibility criteria in the country to which you are applying Before applying, inform your manager so they may support your career development goals Sanofi careers - it all starts with you! Pursue Progress Discover Extraordinary Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Our Team This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. Job Description This position reports to the MSL Regional Director, Immunology (Non-Alliance). Main job responsibilities Uses strong knowledge of relevant disease and disease management protocols, healthcare environment and competitors to articulate the medical and scientific value of our products with external stakeholders. Establishes robust, long-term peer relationships with Key Opinion Leaders and other stakeholder partners. Effectively utilizes the Scientific Engagement Model to plan territory and individual stakeholder (Key Opinion Leaders, HCPs, clinical investigators Payers) engagement interactions consistent with the Field Base Medical Activity Plan and medical function priorities. Critically and routinely evaluates information gained from published studies and stakeholder interactions to develop key insights that deepen our understanding of the market’s needs and opinions of external stakeholders, and therefore contribute to enhancement of medical strategy. Keeps abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities and plays a supportive role in the execution of evidence generation plans to enhance the value of our products in a real-world setting. Collaborates with our Clinical Studies Unit to support clinical trials. Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through appropriate internal processes. Organizes educational meetings or local scientific advisory boards when requested. Supports speaker training. Responds to unsolicited requests for medical information associated with supported products and disease state area. Strong relationship and Link between Sponsor and site staff (instead of relying on CRA) Clinical support and accelerate patient recruitment via scientific exchange Delivery and coordination of site engagement Sharing/delivery of insights back to study teams About You Education: MD, PhD, PharmD or other relevant advanced degree preferred. Work Experience: Previous MSL experience in rheumatology preferred. Skills / knowledge: Ability to interpret key scientific data and translate this information to meet educational and research needs. Utilizes effective, professional communications to cultivate strong working relationships with internal partners and external stakeholders. Exemplary presentation skills with ability to distil complex data into a simple and impactful story. Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in the therapeutic area. Ability to translate expert feedback into appropriate insights. Proficiency with digital tools Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. The salary range for this position is $133,966.88 - 178,622.50 to $223,278.13. In addition to sales incentive (role may my eligible for long term incentive depending on level and performance); all compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com #GD-SG #LI-GZ #IMM2023 At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Job Summary Lead one or more indications/projects in our Immunology Therapeutic Area, under minimum supervision of senior statistical project leader or team leader. Major Duties and Responsibilities Lead a project /one or several indications of a project in immunology clinical development. With minimum direction from senior statistical project leader or team leader, provide statistical support and scientific leadership for responsible projects. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity. Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards. Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload. Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership. Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards. Required Education/Experience PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience. Broad knowledge and good understanding of advanced statistical concepts and techniques. Proven experience in clinical development such as submissions, interactions with regulatory agencies or other external stakeholders. Demonstrated strong project management, interpersonal and communication skills. Experience in immunology and inflammation preferred. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    Our Team: The Senior Director, Field Execution is responsible for overseeing a team of professionals responsible for the execution and delivery of strategic deliverables in Field Design & Deployment, Incentives and Execution adherence in the US Market. This is a critical role leading a team with the ambition to continuously innovate to drive growth and execution for all US businesses. The successful candidate will align and collaborate with all BOS Functional Leaders, other cross-functional support functions, Business Unit and Sales Leaders to ensure excellence in execution. In addition, the candidate will be identifying business efficiencies and developing innovative solutions to address market, industry, and brand opportunities based on modern industry benchmarks & customer engagement models. The Senior Director, Field Execution will report to the Head, Customer Engagement and Execution with strong accountability to the Business Unit General Managers and Sales Leadership. Main responsibilities: Lead a team of 5+ direct reports responsible for the strategy, design, deployment and execution of brand sales architecture, IC plans & contests and execution adherence. Specifically, responsibilities of the candidate will be leading the strategy and continuous improvement of field force architecture; incentives design, optimization & deployment; measurement of field execution & systems adherence using knowledge of modern industry go to market and customer engagement models. Maintains accountability of team performance, transparency and change management. Maintain run state of these activities linked to normal weekly, monthly & quarterly processes. Coordination & support of Sales Operations activities including Quarterly Business Activities, Veeva enhancements, data/reporting enhancements, Field triggers, etc. Create opportunities for efficiencies in brand performance through process improvements, vendor leverage and data analysis, partnering with the brands to implement solutions and track ROI. Recommend changes and make suggestions to BOS and Business Unit teams using Insights and Operational expertise to drive increased performance through innovative ideas and staying abreast of latest industry trends. Collaborate with colleagues in similar roles, cross-business unit to ensure best practice sharing, drive consistency and efficiencies, and effective leverage of support teams. About you 10+ years of experience in Biotechnology or Pharmaceuticals; Undergraduate degree, MBA preferred. Experience leading a team of direct reports in a matrix organization; not afraid to play & coach. High emotional intelligence, change management, communication & financial acumen is required. Demonstrated ability to drive change as a forward thinker within an organization, cultivating support and maximizing contribution from other cross functional team members. Knowledge of modern Go-to-Market models, customer engagement processes and KPIs, tactics including Account vs HCP selling models, KAM & GPO strategies, hybrid selling, rep & home office orchestration, etc. Knowledge of modern incentive compensation plans across therapeutic areas; Lead vs Lag indicators, execution adherence integration, etc. Knowledge of industry standard data sets (IQVIA Xponent & DDD, 867, de-identified SP/HUB data, etc.), systems (Veeva, Salesforce, Snowflake, PowerBI, etc.) and stays abreast of modern technologies, methodologies, and their applications. Acts with integrity and adheres to excellence in governance practices Experience leading without authority in a matrix environment. Excellent presentation skills, ability to tell a story supported by facts. Excellent Project/Program management capabilities Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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    The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs. The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks. The role of the Senior CRD is to: Act as a mentor for other CRDs and Clinical Scientists on a same project/TA Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams. Take on as necessary the CRD role: Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report) Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data Interact with other CRDs in the project, Principal CRD, Global Project Head, The PV Rep, Regulatory and other key functional reps Main responsibilities: Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings Provide oversight and strategic direction to CRD in preparation for and during health authority meetings Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators Evaluates relevant medical literature and status from competitive products About you Medical Doctor (MD) required: GP or specialist (pulmonary/allergy/immunology experience optimal), English fluent (spoken and written) Proven experience in the pharmaceutical industry or CRO, previous experience in clinical development Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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