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 Evidence Innovation in the Next-Gen Immunology franchise will serve as a subject matter expert in designing, conducting, and communicating studies that translate large datasets from existing registries and claims databases into meaningful insights. These insights will help inform and add value in shaping medical, clinical and commercial strategies. The candidate will lead efforts in sophisticated real-world evidence (RWE) studies, with a particular focus on claims data analysis, to generate valuable insights that inform critical decision-making across the organization. Additionally, the successful candidate will oversee and support extensive data analyses from existing registries, clinical trial programs, real-world data, and epidemiological studies relevant to Next-Gen Immunology disease areas of interest.

Reporting directly to the Global Medical Evidence Generation Lead of the Next-Gen Immunology Franchise, the Medical Director will also be responsible for providing strategic insights and oversee operational excellence in aforementioned study types. Responsibilities include regularly updating Integrated Evidence Generation Plans (IEGPs) and implementing tactical activities across various disease areas based on these plans, with a particular focus on leveraging existing real-world datasets and claim databases to generate valuable insights for critical decision-making.

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 real-world and claims database 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 based on the analyses conducted on currently available real-world data sources.

• Accountable for designing and overseeing the execution of claims-based analyses, observational studies, and real-world evidence (RWE) studies.

• 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 claims analyses and other RWE studies.

• Lead the development of analyses based on data available from claims databases 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 claims analyses and 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, advisory boards, and regulatory meetings.

• 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 medical objectives.

Embrace and lead with digital tools & technologies

• Crafting a digital strategy that aligns with the goals of innovatively analyzing claims and other real-world databases available.

• Leading initiatives to adopt innovative digital tools & technologies that can enhance medical research and outcomes.

• Enhancing communication with stakeholders through digital platforms, ensuring clear and accessible dissemination of research findings.

• Fostering interdisciplinary collaborations that leverage digital tools & technologies for advanced medical and clinical 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 to monitor and manage budgets, timelines, and resources for evidence generation projects.

About You

Desired Skills and Competencies

• Exceptional experience in claims analyses, medical affairs, and real-world evidence generation.

• In-depth knowledge of database analysis design, biostatistics, and data analysis.

• Proficient in regulatory requirements and guidelines for medical research and evidence generation.

• Understanding digital platforms to conduct, analyze and disseminate claims data insights.

• Utilizing digital databases/databanks to conduct meaningful analyses 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 or PharmD, or equivalent advanced degree in a relevant field OR Minimum of 10 years of experience in claims research, RWE, medical affairs, clearly demonstrating expertise in developing RWE studies, as well as study management and publications.

• Prior experience in claims database analysis, RWE studies including understanding of 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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)