COMPLETE Clinical Research Director - Ophthalmology - Cambridge

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.

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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.