U.S. Medical Director - Immunology

Main Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

• Advanced degree; MD preferred. Will consider PhD, PharmD, DO.
• Minimum 5 years of clinical experience in Allergy/immunology or minimum 5 years of Medical Affairs experience in the relevant therapeutic area of immunology strongly preferred.
• Demonstrated track record developing and executing medical strategies in the U.S. pharmaceutical market.
• Experience in Medical Affairs launch and lifecycle management activities.
• Experience in clinical trial design and execution (Phase IIIB–IV preferred).
• Deep knowledge of the relevant therapeutic area, including current clinical practice, evolving science, and unmet patient needs.
• Strong scientific and clinical judgment; ability to evaluate evidence and apply it to medical strategy.
• Solid understanding of clinical trial methodology: design, execution, data interpretation, and reporting.
• Knowledge of pharmacovigilance principles and U.S. regulatory processes.
• Familiarity with applicable regulations and guidance (FDA, OIG, OPDP, PhRMA, ICMJE, ISPOR).
• Working knowledge of AI applications in clinical data analysis, evidence synthesis, and medical decision-making.
• Ability to evaluate AI-generated insights critically and guide teams in applying AI-driven approaches to medical strategy, literature review, and scientific communication.
• Comfort working with digital health data sources and analytics platforms relevant to medical affairs.
• Demonstrated experience designing, generating, analyzing, and applying Real World Evidence to support clinical and commercial strategy.
• Familiarity with RWE methodologies (e.g., retrospective database studies, patient registries, pragmatic trials) and common data sources (claims, EHR, patient-reported outcomes).
• Ability to communicate RWE findings to clinical, payer, and regulatory audiences.
• Proven ability to lead cross-functional teams and influence decisions without direct authority in a matrix organization.
• Strong track record of building productive relationships with internal partners and external experts.
• Effective communicator — written, verbal, and presentation — with the ability to translate complex scientific data for diverse audiences.
• Comfortable operating in ambiguous, fast-moving environments; able to prioritize and adapt plans as needed.
• Demonstrated experience leading or supporting organizational change initiatives.
• Highest standards of personal integrity, ethics, and scientific rigor.
• Experience working across diverse cultures and global teams.