Medical Director, Immunology

Job description

Job title: Medical Director, Immunology Location: Cambridge, MA, Morristown, NJ About the Job Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs.  The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients.  We shatter treatment inertia through our commitment to leaving no patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders. The Medical Director, U.S. Immunology functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy for , U.S. Immunology portfolio, above indication, including scientific evidence generation and scientific information exchange with all key stakeholders. As a valued strategic partner with the Medical Field Team, Clinical, Commercial, Regulatory and Market Access this role is essential to success is an outstanding partnership to maximize the value proposition. Externally, the role assists healthcare professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions. This medical leader is responsible for co-developing the U.S. medical above indication strategy and and ensure delivery.  This includes a strong partnership with field teams, global teams, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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: Medical Strategy & Planning: Develop and execute an integrated U.S. Medical Plan covering Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research (Phase IIIB–IV and Investigator Sponsored Trials), including annual budget management. Translate medical strategy into clear, actionable tactical plans; communicate progress to leadership, the Core Team, and execution partners. Ensure medical strategy is aligned with clinical development and commercial objectives, and adapted to local U.S. needs. Provide medical leadership and scientific input to Clinical, Commercial, Market Access, Regulatory, and Sales functions for both marketed products and pipeline assets. Cross-Functional Collaboration: Partner with Field Medical, HEVA, Market Access, Marketing, Legal, and Regulatory teams to ensure scientific accuracy and strategic alignment across all activities. Collaborate with the health economics team to address evidence gaps and support payer-relevant data needs. Manage high-level external stakeholder relationships in coordination with Field Medical leadership, contributing to medical engagement planning and budget oversight. Clinical Research & Evidence Generation: Support execution of U.S. Phase IIIB–IV clinical programs, including protocol development, case report forms, statistical analysis plans, and timely reporting of study data. Oversee all clinical studies in compliance with GCP/ICH guidelines and company standards. Review and approve Investigator Sponsored Trial (IST) concepts and protocols per applicable SOPs. Identify post-marketing clinical trial and registry needs; oversee their management and execution. Ensure all company- and investigator-sponsored trial data are publicly disclosed in a timely, accurate, and balanced manner. Identify and develop research collaboration opportunities to address key clinical questions in the therapeutic area. AI & Data Analytics: Lead the application of AI and advanced data analytics tools to support medical strategy, including evidence synthesis, signal detection, and identification of unmet medical needs. Guide the medical team in evaluating and adopting AI-driven approaches to literature analysis, clinical data interpretation, and scientific communication. Real World Evidence (RWE): Oversee the design, generation, and integration of Real World Evidence studies into the U.S. medical plan to complement clinical trial data and support clinical and payer decision-making. Ensure RWE findings are communicated accurately to internal and external stakeholders and incorporated into medical strategy and publications planning. Scientific Communication & External Engagement: Build and maintain professional relationships with Key Opinion Leaders, researchers, and clinical experts in the therapeutic area. Lead medical and scientific advisory board meetings to gather insights and identify strategic opportunities. Represent Sanofi at medical congresses, advisory boards, and scientific meetings. Provide disease state and product training to internal and external audiences. Medical Review & Compliance: Review and approve promotional and medical materials in compliance with corporate standards and applicable regulations (FDA, OIG, OPDP, PhRMA, ICMJE, ISPOR). Review and approve Regulatory, Safety, Scientific Affairs, and Commercial materials for scientific accuracy. Review applications for independent medical education grants. Review training materials for medical and commercial employees. Partner with U.S. Drug Safety on clinical trial adverse event management, post-marketing safety surveillance, and safety signal communication. Identify and escalate Product Alerts to the Core Team in coordination with Drug Safety, USRAMP, and Global Medical Affairs. About You: Advance Practice Provider with minimum 5 years of relevant clinical experience in allergy/immunology or advanced degree (NP, PA) or minimum 5 years of Medical Affairs experience in allergy/immunology strongly preferred. Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities preferred. High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies. Strong track record in developing and executing medical strategies in the US preferred. High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies. Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale. In-depth understanding of how to conceptualize, design, and conduct clinical trials. Experience in clinical trial design and execution preferred. Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities; ability to translate innovative strategies or solutions into actionable plans. Thinks strategically leveraging knowledge of general business practice, the industry, medical practice and Sanofi strategic objectives to create a team strategy to achieve commitments. Effective internal and external stakeholder management; politically astute with strong cross-functional teamwork and collaboration.