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:- 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.
- 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.
- 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.
- Travel: Ability to travel up to 35% of the time to customers, external meetings, trainings, and other internal meetings.
The salary range for this position is:
$178,500.00 - $257,833.33
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.
