Director Medical Affairs

Role Summary

Senior-level medical and scientific leadership within the Promotional Review Committee (PRC) and Medical Review Committee (MRC), ensuring strategic, scientifically accurate, and compliant promotional and non-promotional materials. Oversee the Medical Information strategy and ensure the development of high-quality, balanced, and scientifically rigorous medical information responses for HCPs and patients. Serve as a senior therapeutic-area expert, maintaining deep knowledge of clinical evidence, competitive landscape, treatment guidelines, and unmet needs to inform brand and medical strategy. Guide cross-functional teams (Commercial, Legal, Regulatory, R&D) in developing scientifically supportable claims, identifying evidence gaps, and shaping data-generation needs.

Responsibilities

• Provides senior-level medical and scientific leadership within the Promotional Review Committee (PRC) and Medical Review Committee (MRC), ensuring strategic, scientifically accurate, and compliant promotional and non-promotional materials.
• Oversees Medical Information strategy and ensures the development of high-quality, balanced, and scientifically rigorous medical information responses for HCPs and patients.
• Serves as a senior therapeutic-area expert, maintaining deep knowledge of clinical evidence, competitive landscape, treatment guidelines, and unmet needs to inform brand and medical strategy.
• Guides cross-functional teams (Commercial, Legal, Regulatory, R&D) in developing scientifically supportable claims, identifying evidence gaps, and shaping data-generation needs.
• Leads Medical Affairs representation in PRC/MRC, providing authoritative medical assessment of claims, references, data relevance, and scientific rigor.
• Ensures promotional materials reflect accurate, balanced, and supportable scientific content and provides proactive recommendations for compliant claim alternatives.
• Oversees Medical Information content development, including standard response letters, escalated inquiries, and cross-functional alignment of medical messaging.
• Partners with Commercial, Regulatory, Legal, and R&D colleagues to support brand strategy, future claim feasibility, and risk-mitigation planning.
• Maintains subject matter expertise in disease state, guidelines, and competitive intelligence to inform internal teams and influence medical strategy.
• Leads medical information and scientific engagement activities at professional congresses, ensuring appropriate training, staffing, and documentation.
• Provides medical training for internal teams (Commercial, MSLs, Medical Affairs) on scientific and promotional standards.

Qualifications

• Advanced scientific degree required (PharmD, PhD, MD preferred).
• At least 6 years of Medical Affairs experience, with PRC/MRC involvement preferred. Senior title may be considered based on tenure and experience, including launch strategy or major regulatory milestone support.
• Deep expertise in clinical development, therapeutic guidelines, competitor landscape, and scientific data interpretation.
• Extensive understanding of FDA promotional regulations, OPDP standards, and medical-legal compliance.
• Excellent written and verbal communication skills with the ability to influence cross-functional partners.
• Strong organizational skills and the ability to manage complex workloads and competing priorities.

Education

• Advanced scientific degree required (PharmD, PhD, MD preferred).