Medical Director, U.S. Immunology

Sanofi

Medical Director managing U.S. Immunology portfolio at Sanofi.

Posted 6/10/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesLead💰 $178,500 - $297,500 per yearWebsite

ATS Keywords

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Hard Skills

clinical trial designclinical trial executionmedical strategy developmentmedical engagement planningdata analysisregulatory compliancebudget managementscientific content reviewhealth economicsclinical research

Soft Skills

communicationcollaborationleadershipstrategic thinkingproblem-solvinginnovationteamworkrelationship buildingscientific judgmentadaptability

Tools & Technologies

FDA regulationsGCPICH guidelinesclinical trial management systemsmedical communication platformsdata management systemsstatistical analysis toolsmedical review softwareproject management toolsbudgeting software

Certifications & Qualifications

PhDPharmDPANPMD

Industry Keywords

Medical AffairsClinical DevelopmentImmunologyLife Cycle Managementinvestigator-sponsored trialspublic healthhealthcare systemsmedical landscaperegulatory environmentscientific advisory boards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
Communicate the details and progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.
Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the tactical budget.
Collaborate with the health economics team to address questions and opportunities
Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials
Provide medical review of applications for independent medical education grants
Provide medical review of training materials for medical and commercial employees
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)
Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and accurate and timely reporting of study data
Oversee conduct of all clinical studies in adherence to both Company standards and government/industry regulations (GCP/ICH)
Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOPs
Identify and co-create research collaboration opportunities within the respective therapeutic area to address key questions in the delivery of patient care
Identify needs for post-marketing clinical trials and registries and oversee their management and execution
Ensure that all data generated by the company or investigator-sponsored trials are publicly presented in an appropriate and timely fashion and in a fair and balanced manner
Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals
Identify and communicate Product Alerts to the Core Team (in conjunction with US Drug Safety, USRAMP, GMA)
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within the respective therapeutic area medical and scientific community
Lead medical and scientific advisory board discussions to identify and elevate medically focused opportunities, resources, and strategic action within >
Foster the establishment and maintenance of external scientific advisory boards and assist in advocacy development
Interact with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in the therapeutic area
Provide disease state and product training to internal and external stakeholders
Remain informed of current developments within the respective therapeutic area medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, and professional associations
Performs other duties as assigned.

Requirements

What you’ll need

Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
Minimum 5 years of relevant experience in Medical Affairs
Strong track record in developing and executing medical strategies in the US
Clinical or medical affairs experience in areas related to Immunology strongly preferred
Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
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.

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave