Senior Medical Study Leader- Vaccines

About The Job

The Senior Medical Study Leader is a member of the Global Medical Program & Study Management team. He/She oversees the medical studies from protocol to final study report. He/she contributes to the trial design and manages, coordinates the planning, the feasibility/evaluation and the execution of clinical trials and observational studies performed as part of the Integrated Evidence Generation Plan / Medical Action Plan. The incumbent is responsible for ensuring that the clinical trials and the Observational/Real-World Evidence studies are executed in line with Sanofi strategy in terms of planning, budget, and quality, and according to local and international regulations.

Main Responsibilities

• Leading/coordinating the clinical trial/study team and working in close collaboration with the Medical Program Leader, Global/Country Medical Expert, Franchise Medical Evidence Generation lead, Pharmaco-Epidemiologist or Epidemiologist, the Clinical Study Management representatives and other functions involved (country release laboratories, external labs, internal labs, Clinical Supply/Commercial Supply Chain, Clinical Study Operations) in the study/trial he/she is responsible of.
• Allocated to a specific Franchise or Product or Region.
• Coordinating and supporting the Medical Study Leader managing studies on their Franchise/Product or the Region they are allocated.
• Contributing significantly to Sanofi initiatives for Process harmonization/improvement/simplification.

About You

• Advanced degree (Master's, PhD, MD, PharmD, DVM), or equivalent, in Life Sciences, Biology, Public Health, Clinical Research, Pharmaceutical Sciences, or a related discipline.
• Minimum of 8 years of experience in clinical research, project management, or a related field in the pharmaceutical, biopharmaceutical, or biotechnology industry.
• Knowledge of GCP/GEP/GPP guidelines and international clinical research regulations.
• Experience in clinical trial management or medical study leadership in vaccines or infectious disease.
• Experience overseeing clinical trials and/or real-world evidence studies from protocol to final study report.
• Familiarity with Pharmaco-Epidemiology and real-world evidence methodologies.
• Experience in international or multi-country clinical studies across more than one regulatory environment.
• Professional project management certification (PMP or equivalent).
• Interest in digital tools and their application for real-world evidence generation.