Medical Director, U.S. Immunology

Pursue Progress, Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

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US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is: $178,500.00 - $297,500.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Medical Director, U.S. Immunology

Location: Morristown, NJ Cambridge, MA

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is proud to support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients. We shatter treatment inertia through our commitment to leaving no patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders.

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. As a valued strategic partner with the Medical Field Team, Clinical, Commercial, Regulatory and Market Access this role is essential to success is an outstanding partnership to maximize the value proposition. Externally, the role assists healthcare professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions.

This medical leader is responsible for co-developing the U.S. medical above indication strategy and ensure delivery. This includes a strong partnership with field teams, global teams, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community.

Main responsibilities:

• 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 the therapeutic area
• 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.

About You

Education, Skills, Experience:

• 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