U.S. Medical Director - Immunology

Sanofi • Cambridge, MA

23h • $206,250 - $297,917 • Hybrid

About The Position

The Medical Director, Immunology serves as the internal medical and scientific lead for assigned therapeutic-area products. The role develops and executes the U.S. medical strategy, drives evidence generation, and engages healthcare professionals, payers, researchers, and other external stakeholders. It partners closely with Field Medical, Clinical Development, Commercial, Regulatory, and Market Access teams to ensure medical plans are scientifically grounded, aligned with U.S. needs, and delivered on time and within budget.

The position leads integrated medical planning across education, communications and publications, health outcomes, safety, and clinical research, including budget management. It supports Phase IIIB–IV clinical programs and investigator-sponsored trials, oversees Real World Evidence generation, and guides the use of AI and advanced analytics in medical strategy. It also leads scientific engagement, medical review, compliance activities, and collaboration across internal functions and external experts.

Requirements

• Advanced degree; MD preferred. PhD, PharmD, or DO will be considered.
• Minimum 5 years of clinical experience in Allergy/Immunology, or minimum 5 years of Medical Affairs experience in the relevant immunology therapeutic area; 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 experience preferred.
• Deep knowledge of the relevant therapeutic area, including current clinical practice, evolving science, and unmet patient needs.
• Strong scientific and clinical judgment, including ability to evaluate evidence and apply it to medical strategy.
• Solid understanding of clinical trial methodology, including design, execution, data interpretation, and reporting.
• Knowledge of pharmacovigilance principles and U.S. regulatory processes.
• Familiarity with FDA, OIG, OPDP, PhRMA, ICMJE, and ISPOR regulations and guidance.
• Working knowledge of AI applications in clinical data analysis, evidence synthesis, and medical decision-making.
• Ability to critically evaluate AI-generated insights 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 such as retrospective database studies, patient registries, and pragmatic trials, and with data sources such as claims, EHR, and 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 written, verbal, and presentation communication skills, including ability to translate complex scientific data for diverse audiences.
• Ability to operate in ambiguous, fast-moving environments and prioritize and adapt plans as needed.
• Demonstrated experience leading or supporting organizational change initiatives.
• High standards of personal integrity, ethics, and scientific rigor.
• Experience working across diverse cultures and global teams.

Nice To Haves

• MD degree preferred.
• PhD, PharmD, or DO considered.
• Phase IIIB–IV clinical trial design and execution experience preferred.
• Minimum 5 years of clinical experience in Allergy/Immunology or minimum 5 years of relevant immunology Medical Affairs experience strongly preferred.

Responsibilities

• Develop and execute an integrated U.S. Medical Plan covering Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research, including annual budget management.
• Translate medical strategy into actionable tactical plans and communicate progress to leadership, the Core Team, and execution partners.
• Align medical strategy with clinical development and commercial objectives and adapt it to local U.S. needs.
• Provide medical leadership and scientific input to Clinical, Commercial, Market Access, Regulatory, and Sales functions for marketed products and pipeline assets.
• Partner with Field Medical, HEVA, Market Access, Marketing, Legal, and Regulatory teams to maintain scientific accuracy and strategic alignment.
• Collaborate with health economics colleagues to address evidence gaps and payer-relevant data needs.
• Manage high-level external stakeholder relationships with Field Medical leadership and contribute to medical engagement planning and budget oversight.
• Support U.S. Phase IIIB–IV clinical programs, including protocol development, case report forms, statistical analysis plans, and timely reporting of study data.
• Oversee clinical studies in compliance with GCP/ICH guidelines and company standards.
• Review and approve Investigator Sponsored Trial concepts and protocols according to applicable SOPs.
• Identify post-marketing clinical trial and registry needs and oversee their management and execution.
• Ensure company- and investigator-sponsored trial data are publicly disclosed in a timely, accurate, and balanced manner.
• Identify and develop research collaborations to address important clinical questions in the therapeutic area.
• Lead application of AI and advanced data analytics to support 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.
• Ensure RWE findings are communicated accurately and incorporated into medical strategy and publications planning.
• Build and maintain relationships with Key Opinion Leaders, researchers, and clinical experts.
• 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.
• Review and approve Regulatory, Safety, Scientific Affairs, and Commercial materials for scientific accuracy.
• Review applications for independent medical education grants and 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.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs; additional benefits information is available through the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior