Medical Director, Immunology

About the Job

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 the U.S. Immunology portfolio, above indication, including scientific evidence generation and scientific information exchange with all key stakeholders.

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

• 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.
• 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.
• A team player; able to collaborate successfully with both internal and external colleagues.
• Broad leadership experience with excellent leadership presence to represent Medical Affairs within the company, to other functions, and to leaders at every level.
• Excellent skills working with experts from other functions, influencing decision-making without authority in a complex and matrix environment.
• Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders.
• Driven to develop and execute optimal strategy meeting corporate objectives while creating pragmatic solutions; comfortable with ambiguity and ability to adapt with agility.
• Strong interpersonal skills with the ability to influence others.
• Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Excellent communication skills both written and oral, including strong presentation skills.
• The highest personal integrity; committed to ethics and scientific standards.
• High energy and absolute commitment to a culture that operates with high ethical standards.
• Strong analytical skills; comfort managing through ambiguity.
• Understanding and success in dealing with different cultures.
• Proven ability to utilize appropriate time and project management strategies and agility, to manage complex environment and excellent ability to prioritize and manage expectations.
• A lifelong learner who consistently seeks opportunities to learn.
• Knowledge of pharmacovigilance and local regulatory process.
• Proven record of successful change management, a Change Champion mindset.
• Digital literacy.
• Ability to travel up to 35% of the time to customers, external meetings, trainings, and other internal meetings.