Global Medical Director, Evidence Generation – Innovation and Partnerships

Job title: Global Medical Director, Evidence Generation – Insights and Strategy

Location: Cambridge, MA, Morristown, NJ

About the Job

Sanofi's ambition is to become the leading Immunology company in the coming years. With 12 potential breakthrough medicines and vaccines leveraging our strength in Immunoscience and an unprecedented number of active phase 3 projects in 2025, Sanofi's Specialty Care Immunology team is rapidly expanding.

Specialty Care Medical Affairs have a vision to be the leaders in patient and scientific knowledge and insights to improve clinical care. We do this by generating and curating the most critical patient and scientific evidence and by being highly credible partners shaping scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory, R&D, market access and external affairs to develop and launch first in class and best in class therapeutic solutions that address highest unmet needs.

The Director for medical epidemiology and RWE in the Next-Gen Immunology franchise will act as a subject matter expert in designing and implementing epidemiological research studies, as well as providing consultation on epidemiological study designs including statistical plans. The successful candidate will lead and support disease registries, real-world evidence (RWE), and epidemiological studies for Next-Gen Immunology pipeline assets.

Reporting directly to the Global Medical Evidence Generation Lead of the Next-Gen Immunology Franchise, the Medical Director will also be responsible for offering strategic insights and ensuring operational excellence in the aforementioned study types. This includes regular updates to the Integrated Evidence Generation Plans (IEGPs) and executing tactical activities across various disease areas based on the IEGP.

The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, prioritize, and execute study design and analytical activities. The ideal candidate will contribute significantly to the strategic planning for IEGPs, scientific communications, and medical education related to disease areas, patient unmet needs, and study outcomes. Additionally, the candidate will be accountable for performing, quality-checking, and refining analyses, as well as explaining and interpreting findings for internal colleagues, management, and external stakeholders.

This position requires a matrix team leader who takes a hands-on approach. Successful collaboration across cross-functional stakeholders is essential for this role, necessitating excellent communication skills and comfort working with non-co-located colleagues.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities

• Provide strategic and operational input into clinical development plans and the development of integrated patient journey to ensure robust evidence generation.

• Accountable for designing and overseeing the execution of phase 3b, phase IV clinical trials, observational studies, claims database analyses and real-world evidence (RWE) studies.

• Develop and implement analysis plans to investigate the natural progression of the disease, including characterization of disease endotypes/phenotypes or patient diagnostic/care pathways and real-world treatment outcomes using observational study (i.e. registry) data.

• Collaborate with the scientific communication team to prepare conference abstracts and manuscripts for publication in peer-reviewed scientific journals to publish the results and scientific insights arising from observational studies.

• Lead the development of analyses based on data available from various registries and observational studies to support identifying and defining the right target population for any asset and/or the clinical trials recruitment strategy.

• Collaborate with R&D teams (e.g., clinical development) to provide analyses to support clinical trials (e.g., historical cohorts, outcome trends in specific patient populations) and Global project/brand teams to support launches.

• Ensure quality and timely preparation of deliverables through efficient collaboration with internal   team and external vendors.

• Manage SBO Medical Services hub or vendor support to