Job title: Medical Director - Immunology
- Location: Cambridge, MA, Morristown, NJ
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- 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).
Scientific & Medical Expertise:
- 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).
AI Literacy & Digital Capabilities:
- 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.
Real World Evidence (RWE) Experience:
- 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.
Leadership & Collaboration:
- 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.
The salary range for this position is:
$206,250.00 - $297,916.66
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.
