Hybrid Medical Director, Rheumatology

at Sanofi

• Job title: Medical Director, Rheumatology
• Job type: Full Time
• Experience level: Lead
• Salary: $178,500 - $257,833 per year
• Degree requirement: No Education Requirement
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Cambridge, United States

About the role

• Medical Director leading medical strategy and execution for rheumatology products at Sanofi. Collaborating with cross-functional teams to optimize patient care and treatment outcomes.

Responsibilities

• Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, 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 rheumatology 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 rheumatology 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 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, and manage MSL 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 MSL 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).

Requirements

• 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 Rheumatology and/or 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

Benefits

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