Senior Medical Study Leader- Vaccines

Job Title: Senior Medical Study Leader

Location:Morristown, NJ

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.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.

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.

Main Responsibilities:

• The Senior Medical Study Leader is leading/coordinating the clinical trial/study team and works 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.

• The Senior Medical Study Leader is allocated to a specific Franchise or Product or Region.

• The Senior Medical Study Leader is coordinating and supporting the Medical Study Leader managing studies on their Franchise/Product or the Region they are allocated.

• The Senior Medical Study Leader also contributes significantly to Sanofi initiatives for Process harmonization/improvement/simplification.

About You:

Basic Requirements

• 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

Preferred Qualifications

• 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

Why Choose Us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Bring the miracles of science to life alongside a supportive, future-focused team.

• 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.

• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.

• Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.

• Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.