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 complete epidemiology/biostatistics deliverables (including statistical analysis plans, table shells, and programming specifications for implementation by internal statistical programming team and/or contractors).
• Prepare oral and written presentations and reports to effectively communicate results to internal and external stakeholders.

Stakeholder Engagement

• Build and maintain relationships with selected Global Key Opinion Leaders (KOLs), academic institutions, and research organizations to identify evidence gaps and opportunities for collaboration.
• Act as a representative of evidence generation team from Sanofi at scientific conferences, and advisory board meetings, where necessary.
• Collaborate with biostatisticians, data scientists, and external partners to leverage advanced analytics and innovative methodologies.
• Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs, HEVA, Market Access, and Commercial to align evidence generation activities with our medical objectives.

Embrace and lead with digital tools & technologies

• Developing and leading a digital strategy that aligns with the goals of epidemiological research and innovative data analyses.
• Leading initiatives to adopt innovative digital technologies that can enhance epidemiological research and outcomes.
• Enhancing communication with stakeholders through digital platforms, ensuring clear and accessible dissemination of findings.
• Fostering interdisciplinary collaborations that leverage digital technologies for advanced research opportunities.

Compliance and Quality Assurance

• Accountable for ensuring all evidence generation activities comply with regulatory requirements, Good Clinical Practice (GCP), and company policies.
• In charge of implementing quality assurance processes to maintain the integrity and credibility of generated evidence.
• In charge of monitoring and managing budgets, timelines, and resources for evidence generation projects.

About You

Desired Skills and Competencies

• Extensive experience in research including clinical studies, RWEs and claims database analyses
• In-depth knowledge of clinical trial design, biostatistics, and data analysis.
• Proficient in regulatory requirements and guidelines for clinical research and evidence generation.
• Understanding of digital epidemiology platforms to conduct, analyze and disseminate epidemiological research
• Utilizing digital databases/databanks to conduct epidemiological and RWE studies
• Proven leadership and management skills in overseeing cross-functional teams in a global context.
• Excellent project management capabilities with the ability to prioritize and manage multiple projects concurrently.
• Outstanding written and verbal communication skills.
• Strong interpersonal abilities, enabling the establishment and maintenance of relationships with both internal and external stakeholders.
• Exceptional analytical skills for interpreting complex data and generating actionable insights.
• Effective problem-solving skills with a proactive approach to identifying and addressing challenges.
• High ethical standards and a commitment to maintaining scientific research integrity.
• Strong attention to detail with a commitment to quality.

Qualifications Required

• MD or PhD in Epidemiology/Public Health, or equivalent advanced degree in the relevant field, OR Minimum of 10 years of experience in clinical research, RWE/Epidemiology, medical affairs, clearly demonstrating expertise in developing RWE/epidemiological studies, as well as study management and publications.
• Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology, design, management, and execution.
• Demonstrated experience in leading global evidence generation initiatives as well as study management and publications.
• Professional fluency in English

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 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.

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.