Jump to content

Sanofi

Members
  • Posts

    2
  • Joined

  • Last visited

    Never

Everything posted by Sanofi

    • Full Time
    • 0
    • 0
    Job Summary Lead one or more indications/projects in Rare Disease or Rare Blood Disorder 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 rare disease and rare blood disorder 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 rare diseases or rare blood disorders 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 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
    • 0
    • 0
    JOB SUMMARY: We are seeking a highly motivated and talented Postdoctoral Researcher to join our Protein Engineering group within Sanofi LMR (Large Molecule Research) department to work on a novel mechanism of action for agonist antibodies. This position will work closely with experienced scientists in a dynamic, fast-paced, and highly collaborative environment. Our Protein Engineering group has a great track record of patents and publications. We have a state-of-art structural biology capability within the group, offering a unique opportunity to collaborate closely with protein engineers, structural biologists, and computational biologists. RESPONSIBILITIES: The successful candidate should have the expertise in the structural biology and yeast display-based antibody/protein engineering. Previous experience in the field of agonist antibodies for immuno-oncology therapeutic area is highly desired. The project will involve a combination of protein production, biochemical/ biophysical characterization, yeast display-based engineering, and structural biology analysis and techniques. The project will focus on expanding the recently discovered mechanism for agonistic antibodies to produce a generic platform modality through antibody engineering and structural biology. Design and perform structural biology experiments, such as X-ray crystallography and cryo-EM, to understand the mechanism of action of agonistic antibodies. Analyze structures and design structure-based mutations. Perform yeast display-based antibody engineering. Perform protein expression and purification, and biophysical/biochemical characterization of engineered antibodies, including ELISA, SPR, and mass photometry. Analyze and interpret data independently and communicate results to the team and stakeholders. Publish research findings in peer-reviewed journals and present at scientific conferences. REQUIREMENTS: Ph.D. in Structural Biology, Biochemistry, Molecular Biology, or related fields. Experience with structural biology techniques and protein/antibody design engineering is required. Experience with yeast display technology for antibody engineering is highly desired. Strong background in protein engineering, molecular biology, and protein purification is highly desired. Experience in the field of agonist antibodies for immuno-oncology therapeutic area is desired. Ability to work independently, design and execute experiments, troubleshoot technical issues, and analyze and interpret complex data. Excellent communication skills and ability to work collaboratively with other team members. Strong track record of scientific publications in peer-reviewed journals. 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
    • 0
    • 0
    About the Job: Our Team: In GQA, it is our mission to define the Sanofi Global Quality Audit process and to coordinate its implementation across the group. We are committed to provide an accurate, independent assessment of Sanofi M&S / R&D sites, country offices and key third parties for compliance with Sanofi Quality Policy requirements and applicable regulations through constructive audit and inspection support activities. We lead the external liaison group and manage our external relations to contribute positively to the development of regulations, guidance, policies, and initiatives that are external and relevant to Sanofi. We are change leaders that challenge the current processes against external benchmark and industry trends, to target the best-in-class audit process and organization. Main responsibilities: Leadership of the Global Quality Audit team. Provides direction and support for the GQA team for Sanofi site regulatory inspections Ensures close interaction with the Chief Quality Officer and Global Quality Senior Leadership team to ensure good governance of the GQA activities, audit findings and related CAPA. Interacts with Sanofi Internal Audit and Internal Control to identify and implement audit approaches that provide synergies and benefit to Sanofi. Implements Risk based approached and drives the transformation within GQ-Change management mind set role modelling play to win behaviours About You: Experience: FDA & external liaison advocacy expert Soft skills: risk-based decision making, relationship management, change management, transformation mind-set, empowering teams and leading by influence Technical skills: Regulations and golden standard auditing practices Languages: Fluent in English, French is 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-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
    • 0
    • 0
    Senior Principal Scientist – Medicinal Chemistry DESCRIPTION: Integrated Drug Discovery (IDD) is the small molecule drug discovery platform within Sanofi. IDD is an international, interdisciplinary group that spans medicinal chemistry, structural biology, screening, biochemistry, biophysics, cellular pharmacology, delivery technologies, sample management and more. Our vision is to deliver valuable, high quality synthetic drugs of varying modalities to improve the lives of patients. Our mission is to provide innovation and key enabling technologies to drive the discovery of synthetic small molecules and emerging synthetic modalities as drug candidates in the Sanofi Research Portfolio; to deliver high quality science and innovative approaches to drug discovery, and to perform as a highly collaborative flexible and forward-looking organization with broad impact across the Sanofi pipeline. We are seeking a dynamic and experienced medicinal chemist to join our Cambridge, MA-based team as a Senior Principal Scientist. KEY DUTIES AND RESPONSIBILITIESThe successful candidate is a proven, experienced team leader with a track record of success in medicinal chemistry and multidisciplinary drug discovery. A Senior Principle Scientist is responsible for applying deep scientific expertise and judgement to initiate, design, and direct medicinal chemistry in support of research goals; is an expert in analyzing, interpreting and communicating scientific content to teams and stakeholders; demonstrates continuous growth in depth and breadth of scientific knowledge and understanding of strategic goals of group, team and company; successfully works as an impactful contributor, and as a leader of project teams and transverse initiatives; is an experienced and supportive manager and mentor of other medicinal chemists; has an established and growing reputation in the external scientific community through high impact publications, productive scientific collaborations and active participation in conferences. QUALIFICATIONS PhD in Organic/Medicinal Chemistry with 7+ years of experience in a pharmacuetical/biopharmapharmacuetical environment; or Master’s degree in Organic Chemistry with 9+ years of experience in a pharmacuetical/biopharmapharmacuetical environment; or Bachelor’s degree with 12+ years of experience in a pharmacuetical/biopharmapharmacuetical environment Exceptional technical skills and demonstrated ability to work and thrive in a collaborative cross-functional team setting; proven ability to analyze complex data sets, draw conclusions, and design follow-on experiments Experience in all phases of the small molecule discovery process from hit ID to candidate nomination Demonstrated track record of intellectual contributions in drug discovery as evidenced by impactful peer-reviewed publications, presentations, patents, and project achievements Strong interpersonal and communication skills (written and verbal) Experience in managing, coaching, and developing less experienced chemistry team members Experience working with CROs and external collaborators Comfortable and efficient in fast moving complex global 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. #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
    • 0
    • 0
    JOB DESCRIPTION: Sanofi Genomic Medicine Unit (GMU) CMC is dedicated to building best-in-class CMC technology and successful development of Sanofi gene and cell therapy programs that will bring cures to patients with unmet medical need. The Vectorology group within GMU CMC Predevelopment is responsible for the engineering of next-generation plasmids to improve the viral vector production platforms. We are seeking a highly motivated CO-OP student to join the team. The successful candidate will work with his/her supervisor to design, plan, and conduct molecular biology and cell culture experiments to investigate the impact of expression vector modification and/or host cell line engineering on recombinant AAV (rAAV) production. The successful candidate will have the opportunity to work both independently as well as part of the team to achieve group objectives. The candidate will have the opportunity to develop a diverse skill set in molecular biology and cell culture. Through this experience, she or he will gain knowledge of rAAV production platforms and optimization strategies. KEY RESPONSIBILITIES: Work with supervisor to plan, design and execute experiments, analyze data, and interpret experimental results. Conduct molecular biology assays such as, molecular cloning, plasmid preparation, quantitative PCR etc. Perform mammalian cell culture experiments like cell maintenance, cell transfection. Document laboratory experiments in a timely manner. BASIC QUALIFICATIONS: Currently enrolled in a molecular biology, cell biology or similar BS, MS or Ph.D degree program. PREFERRED QUALIFICATIONS: Experience with molecular biology, mammalian cell culture/aseptic techniques. Good organizational skills. Ability to use basic Microsoft office software such as Excel and PowerPoint. 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
    • 0
    • 0
    mRNA Associate Director, Drug Substance Platform Development - Vaccine In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before. That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams. Bring your ambition and optimism for the future to Sanofi. About the Opportunity As an Associate Director within the Global CMC Drug Substance Development function, you will provide leadership to a group composed of scientists and engineers focusing on developing the next generation mRNA platform process within the mRNA CoE. The candidate will be responsible for designing and developing robust mRNA processes with stage appropriate control strategies from Phase 1 to approval. KEY RESPONSIBILITIES FOR POSITION About growing with us for winning with us In this role you will…. Build and lead a group of scientists and engineers to design and develop a scalable platform process for synthesizing and purifying mRNA drug substance Work with CMC Product Development & Industrialization team to develop processes that meet manufacturability requirements Develop plans to maintain, improve, and develop new competencies and assess resources (including personnel, facilities and equipment) necessary to meet current and future goals Coach and mentor direct reports to ensure continued development of platform competencies Establish criteria for measurable performance of the team and monitor with KPIs Deliver QbD based work packages to progress programs from pre-IND to approval including CQA definition, product and process design, characterization, and control strategy Ensure that platform is adhering to current regulatory practices and cGMP guidelines. Ensure safety of teams and compliance with good research practices, local and Global HSE/biosafety regulations Develop PAT for enhanced process monitoring and control. Actively participate and drive Sanofi’s position in conferences and scientific collaborations, with academia, industry, and regulatory agencies COMPETENCIES / REQUIREMENTS FOR POSITION About you Qualifications/ Education & Work Experience MS with > 13 years or PhD with > 7+ years of experience developing mRNA drug substance development Understanding of complex R&D landscapes globally, ability to identify cutting-edge technologies and new directions, strong academic and biotech/pharma scientific networks Experience leading multi-disciplinary teams Good oral communication, management, and interpersonal skills Results oriented, collaborative, decisive, strategic innovative thinker with passion for developing people Fluent in English Ability to travel domestic and international 10 – 20% 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 #mRNA 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
    • 0
    • 0
    Department Description Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives. Senior Manufacturing Compliance Engineer uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations. Core Responsibilities Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines. Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action. Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change. Conducts complex document revisions and /or document management including batch production records, manufacturing procedures, and cross functional procedures. Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory and compliance. Trains new Manufacturing Compliance Engineers. Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services. Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion. Effectively utilizes Microsoft office applications. Creates and presents trending and metrics reports. Provides direction to the Manufacturing Compliance Engineers in the absence of the operations manager. Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget. Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services. Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results. Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues. *Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. Leadership Qualifications: An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes: Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. Being honest and treating people with respect and courtesy. Constantly striving to make Sanofi's a great place to work and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs Basic Qualifications Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 3-4 years in a cGXP manufacturing environment or a master’s degree in Sciences, Technical, Engineering or Advanced degree and 2 years of experience in cGXP manufacturing environment. Knowledge and understanding of Manfacturing. Knowledge of GXP regulations and guidance. Minimum of 2 years' experience with deviation management systems (e.g. Trackwise, Viva). Excellent critical thinking and technical writing Excellent written and oral English language skills. Proficient with change control requests, CAPAs and deviation quality systems Proficient in critical thinking and technical writing Experience leading cross functional teams and facilitating team meetings. Ability to influence in a cross-functional environment. Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents. Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects. Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time. Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery. Special Working Conditions Ability to gown and gain entry to manufacturing areas. Ability to work off shift hours, seldom, to support product release. 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
    • 0
    • 0
    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, Resp & GI Non-Alliance Immunology. 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, 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. About you List the requirements that are ideally required to be qualified for the position. Remember, the fewer the restrictions, the easier it is to expand the talent pool and increase the diversity of candidates. Education: MD, PhD, PharmD preferred. Work Experience: Previous MSL experience in dermatology 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. ​ 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. 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 #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.
    • Full Time
    • 0
    • 0
    HEOR Director - Rare Disease Purpose of Role: To support rare disease portfolio to plan and generate robust evidence to maximize the value propositions from both a global and US perspectives working within the market access team. Major Activities / Key Responsibilities Health Economics strategy, evidence generation and reimbursement support Oversee and guide development of 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 overseeing direct report at director level on product launches and post launch evidence generation activities. The incumbent will also lead 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 Manage the HEVA evidence generation strategy Manage team budgets and execution of ongoing studies according to budget and timeline expectations Identify new HEVA evidence generation opportunities to maximize lifecycle management Assist countries in developing or adapting health economic models and other materials for reimbursement, payer objection handling and other purposes 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. 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. 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 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. Serves as a resource to commercial organization in terms of pricing, positioning and reimbursement of products based on economic evaluations. 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. 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
    • 0
    • 0
    Position Overview Reporting to Global Head of Translational and Nonclinical Biostatistics (TED) under Global Biostatistical Sciences (GBS) in Sanofi Vaccine Business, the Head of Nonclinical Biostatistics is responsible for the statistical oversight of activities in clinical assay characteristics/qualification/validation for late phase clinical testing of immunogenicity/antibody responses; CMC analytical science for drug products and drug substance assay statistical strategies in design and validation/qualification. Responsible to provide statistical expertise in responding to regulatory questions in clinical studies related to clinical assay testing. In addition, ensure the outsourced assay activities are aligned with Sanofi standard and regulatory requirements. People’s management of direct reports. Key Responsibilities: Key interface with internal and external stakeholders for below statistical support: Clinical testing Internal (late phase clinical testing); lead the statistical activities in assay development, qualification, validation and testing to ensure the science, quality and compliance. Responsible for regulatory response and medical journal submissions. Clinical Testing External; lead the stats contents when applicable in assay development, qualification, validation and testing to ensure the science, quality and compliance at CRO. Responsible for regulatory response and medical journal submissions when applicable. Research Assay development; Provide stat support to research assay development and qualification. Responsible for regulatory response and medical journal submissions when applicable. Provide statistical support for external lab evaluation and activities relate to outsourcing (qualification, bridging, concordance, etc.) Support new technologies for testing and diagnostics: Provide statistical support on bioassay, biomarker, diagnostic, serology testing, etc. External collaboration: represent Sanofi in external collaborations, e.g., IMI consortiums, industry standard and white paper when involving new technologies related to testing and diagnostic assay. CMC support: Lead the statistical support of analytical method development and qualification/validation to ensure science, quality and compliance. Responsible for regulatory response and medical journal submissions. Design of Experiment (DoE) application and training: apply statistical and modern experimental techniques to improve assay efficiency and to improve existing processes by identifying and reduce source of variabilities. Develop and deliver statistical training materials as well as software tools for scientists. People’s management responsibilities including line management, coaching, mentoring, empowering and performance review for direct reports. Manage and mentor direct reports with technical supervisions/inputs including project assignments, review statistical analysis plan and report; workload tracking and managements. Set up objectives and development plans with individual staff members and provide on-going mentoring and guidance. Continue to build team, coach and empower staff to allow them to reach their full potential to best support projects. Performance evaluation of direct reports according to HR guidelines. Create a supportive and stimulating working environment. Working with other TED and GBS Lead, manage employees in a matrix organization (if employee works across functions) Hiring, and managing new staff when needed. Advocate sound statistical principles Educate scientists to apply the sound statistical principles in study conducts including design, data handling, analysis and reports to increase the success rates moving the programs to clinical stages. Develop and deliver statistical trainings to scientists. Continuous improvement of the preclinical biostats platform to make it a high performing organization Focus on company goals to identifies areas for improvement in both projects and operational aspects and proposes initiatives to address challenges. Contributes to GBS and TED initiatives from preclinical perspectives to make the organization highly efficient. Communicates nonclinical vision and strategy, and supports employee involvement in departmental activities Requirements Education, Experience and skills: A Ph.D. or MS in statistics/biostatistics or related discipline with at least 8-10 years of pharmaceutical experience in related areas. Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic testing. Managerial experience in leading a team to support global functions is desired. Demonstrated strong project management skills and multitasks under time pressure. Effective communication skills Excellent English writing skills in responding to internal and external reviews. Ability to meet the regulatory standard when document the statistical sections. Ability to represent Sanofi in cross-company activities such as consortiums or professional associations. 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.
    • Full Time
    • 0
    • 0
    Senior Principal Scientist, Preclinical Safety Projects, US Job Overview and Responsibilities: This position will provide the department of Preclinical Safety a wide range of support associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams of Sanofi Group. This position would provide toxicology scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to: Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs) Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis Participate in issue-resolution teams, where she/he will be required to contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development. Participate in Preclinical safety-US and global Preclinical safety Department activities (staff meeting, scientific forums, etc.), and special projects Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities Serve as internal expert for scientific issues related to nonclinical safety issues Ensure high scientific standards and adhering to requested timelines in all aspects of the position Basic Qualifications: PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience At least 5-8 years of relevant Toxicology experience Authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs) Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules Excellent verbal and written communication skills Demonstrate leadership and expertise in preclinical safety disciplines Preferred Qualifications: The candidate should have knowledge in biochemistry, toxicology, pharmacology, Immunology, physiology, and statistics. DABT certification is preferred, but not required. Experience as a GLP Study Director is preferred. Location Information: The successful candidate will report to the Head of Preclinical project in the US This position is based in Cambridge, MA. 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
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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.
    • Full Time
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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
    • 0
    • 0
    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.
×
×
  • Create New...