Senior Director, Medical Affairs Operations and Strategy

Responsibilities:

• In collaboration with Medical Affairs leadership, develop, operationalize, and continuously refine the Medical Affairs strategy, helping to translate strategic objectives into actionable project plans, KPIs and timelines
• Oversee and ensure the quality of the departmental strategic planning processes, including operations tasks, and other activities related to pipeline compounds
• Leads organization, updating and communication of strategic plans to internal and external stakeholders
• Foster strong partnerships with internal teams such as Clinical Development, HEOR, Commercial teams, & finance to ensure alignment and efficiency in medical activities
• Develop, maintain, and update Medical Affairs SOPs and quality documentation to support compliant, efficient, and consistent operations
• Work in close collaboration with Compliance, Regulatory, and Legal counterparts to deelop materials that that align with regulatory requirement and industry best practices
• Implement and refine operational governance frameworks for scientific review and medical communication standards
• Ensures material development for internal and external use is aligned with organizational goals and priorities and meets compliance, regulatory, and legal requirements
• Establish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs
• Monitor timelines, risks, and deliverables; provide transparent reporting to leadership on progress and resource needs
• Coordinates cross-functional project teams to ensure timely execution and integration of medical insights into decision-making
• Maintenance of program budget trackers and financial forecast for Medical Affairs programs
• Implement and optimize systems and tools to enhance productivity and data management
• Develop and track key performance indicators (KPIs) to measure the effectiveness Medical Affairs operations
• Collaborate with IT to implement and optimize technology solutions for medical operations
• Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions

Skills and Competencies:

• Strong understanding of Global Medical Affairs functions and their interconnections with other departments
• Technical knowledge in Veeva CRM, Veeva Vault, KOL Mapping Systems, etc.
• Excellent project management skills with the ability to manage initiatives simultaneously
• Demonstrated ability to work effectively with cross-functional teams in changing environments
• Innovative mindset with the ability to identify and implement creative solutions for global challenges

Requirements:

• Doctorate degree (PharmD, MD, DO, PhD)
• 10 plus years of industry experience with demonstrated high-level professional knowledge and skills in the areas of medical affairs and R&D
• Experience in both pre launch and post-launch medical affairs activites. Experience with Psychiatry/CNS is a plus
• Demonstrated ability to create and lead successful cross-functional teams in changing and competitive environments
• Experience with Early Access Programs (EAP) is a plus
• Candidates must be comfortable working independently in a fast-paced environment

The starting base pay range