Medical Director responsible for managing clinical operations and providing strategic advice at Elevance Health. Overseeing health services and ensuring quality and cost - effectiveness in care delivery.
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
Job title
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Degree requirement
No Education Requirement
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