Clinical Research Director

Sanofi • Cambridge, MA

3d

About The Position

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Reporting to the Global Project Head, the CRD leads clinical trial strategy of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team further develops a compound through life cycle management. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

• MD degree or equivalent, with Medical Oncology fellowship.
• Hematology/Oncology fellowship or experience (4+ years) in Oncology Development
• Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years),
• Experience in clinical development, late-stage preferred
• Demonstrated ability to interact productively with external investigators
• Demonstrated ability to work with a multifunctional team to achieve project milestones
• Understanding of and willingness to meet applicable regulatory, quality and compliance standards

Responsibilities

• Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to: Authors abbreviated protocol. Reviews the final protocol and protocol amendments. Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. Reviews the study specific committee charters. Leads study specific committees with operational support. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
• Participates and contributes to regulatory and safety documents and discussions Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans
• Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP
• Participates in Advisory Committee preparation
• Scientific data evaluation and authorship Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate
• Supports the planning of advisory board meeting.
• Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree