Vice President, Medical Affairs

About the role

The Vice President, Medical Affairs leads implementation of Medical Affairs strategy across the product portfolio, setting direction for pre- and post-launch activities and ensuring effective engagement with the medical and scientific community throughout the product lifecycle. This role has oversight of Field Medical Affairs (the Medical Science Liaison organization); Medical Affairs Program Leads; Epidemiology & Real-World Evidence; Medical Operations, Scientific Affairs and Patient Advocacy. The VP partners closely with Clinical Development, Regulatory, and other departments on cross-functional launch planning, data generation strategy and life cycle management; as well as ensuring all external engagements with HCPs, advocacy groups and allied health care functions globally are compliant with industry country codes of conduct and regulations.

Responsibilities

• Provide input and lead implementation of the medical affairs strategy across the product portfolio, including pre- and post-launch activities
• Development and oversight of HCP engagement strategy, interactions, advisory boards and consulting activities
• Identification of data generation needs and development of appropriate strategies (i.e. phase 3b, 4, real world evidence approaches) for products both in development and as part of life cycle management activities
• Provide technical opinion, appraisal and oversight of sponsored research agreements and investigator initiated trials
• Review and provide recommendations at relevant governance forums for grants and sponsorship requests; as well as provide oversight of relevant processes
• Partner with Clinical Development, Regulatory, Commercial, and Market Access on cross-functional launch and lifecycle planning.
• Build, lead, and develop the medical affairs function ensuring relevant processes and tools are in place for effective execution of medical strategy
• Ensure all activities within the medical affairs group comply with applicable laws, regulations, and industry codes of conduct inclusive of review and final approval for external company facing materials with HCPs and allied professionals
• Represent Field Medical and Epidemiology/RWE in due diligence and business development activities.
• Serve as a senior scientific spokesperson at external congresses and with healthcare stakeholders.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Medical degree (MD or DO) required; board certification in immunology, rheumatology, internal medicine, or a related specialty, with clinical experience in autoimmune disease, is strongly preferred
• 10+ years of progressive Medical Affairs leadership in pharmaceutical and/or biotechnology industry.
• 5+ years managing multiple teams and/or functions (e.g., MSLs, RWE, medical information) at the director level or above.
• Experience building, scaling, and matrix Medical Affairs organization including leading global MSL/field medical teams and data generation activities across multiple therapeutic programs and product launches.
• Experience with label-enabling Phase 3b and 4 trial design and execution required, with a demonstrated track record of successful interactions with global health authorities (e.g., FDA, EMA, PMDA, CDE).