Clinical Research Director, I&I
Sanofi · Cambridge, MA · 3 wk ago
On-siteResearchFull-time
About the role
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.
Main Responsibilities
- Contributes to the development of the clinical strategy and plan.
- Led the development of the Abbreviated Protocol and Protocol development.
- Represents the clinical function on Clinical Study Teams and other teams as appropriate.
- Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug.
- Ensures that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end).
- Interacts with opinion leaders and external consultants.
- Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project.
- Ensures clinical data meets all necessary regulatory standards.
- Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities).
- Participates in Advisory Committee preparation.
- Ensures timely submission and dissemination of clinical data.
- Supports the planning of advisory board meetings.
- Establishes and maintains appropriate collaborations with knowledge experts.
About You
- Medical Doctor with hematology/ transplant clinical expertise preferred.
- At least 2 years’ experience in pharmaceutical drug development or clinical research.
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus.
- Strong scientific and academic background with deep understanding of the disease.
- Clinical research or pharmaceutical experience in the immunology/hematology/transplant field.
- Knowledge of drug development and in immunology/ hematology/ transplant.
- 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.
- Fully fluent in English (verbal and written communication).
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.
Why Choose Us
- 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 a 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.