Director, Medical Affairs Operations

Overview of Role

The Director, Medical Affairs Operations will lead the global Medical Affairs Operations function and provide strategic oversight for the execution of operational activities that support Medical Affairs strategy across regions. This role serves as a key business partner to Medical Affairs leadership and collaborates closely with Compliance, Legal, Finance, Clinical Development, and external vendors to ensure consistent, compliant, and efficient execution of congress sponsorships, advisory boards, scientific engagement programs, healthcare professional interactions, vendor management, contracting, budgeting, systems, and operational excellence initiatives. The Director will establish scalable processes, drive global alignment, manage vendor relationships, build operational capabilities, and oversee a global team supporting Global Medical Affairs operations, while supporting launch readiness, organizational growth, and the successful execution of strategic initiatives across the Medical Affairs organization.

Responsibilities

• Global Medical Affairs Operations Leadership: Lead operational planning and execution of Medical Affairs initiatives across regions, therapeutic areas, and functions. Establish scalable frameworks, policies, processes, and best practices that improve efficiency, quality, compliance, and organizational readiness.
• Team Leadership and Development: Lead, coach, and develop a high-performing global Medical Affairs Operations team, including congress sponsorship, US operations, and Europe-based operations roles. Establish goals, performance objectives, development plans, and operating rhythms that support team effectiveness and future growth.
• Cross-Functional Partnership and Governance: Partner with regional Medical Affairs leaders, Compliance, Legal, Regulatory Affairs, Finance, Procurement, Clinical Development, IT, and external vendors. Ensure consistent execution of operational processes worldwide and act as an escalation point for operational challenges and cross-functional issue resolution.
• Vendor and Financial Management: Oversee Medical Affairs vendor strategy, selection, contracting, performance management, SOWs, purchase orders, budgets, forecasting, and invoice reconciliation. Partner with Finance and Procurement to optimize resource utilization and ensure external engagements follow FMV requirements, company policies, and industry standards.
• Congress, Advisory Board, and Scientific Engagement Operations: Provide oversight for national, regional, and international congress sponsorships, exhibits, medical booths, scientific exchange activities, advisory boards, investigator meetings, and individual customer engagements. Establish standardized planning processes, operational metrics, vendor oversight, and resource plans to support consistent execution across regions.
• Compliance and Operational Risk Management: Ensure Medical Affairs operations adhere to healthcare compliance requirements, Sunshine Act reporting obligations, FMV standards, company policies, and applicable industry regulations. Maintain audit-ready documentation, monitor emerging requirements, and identify operational risks with appropriate mitigation plans.
• Systems, Metrics, and Analytics: Lead development and implementation of dashboards, reports, KPIs, and operational metrics to measure program effectiveness, congress investments, vendor performance, and operational activities. Partner with IT and Digital teams to implement systems and use analytics to identify process improvements and resource allocation opportunities.
• Strategic Planning and Launch Readiness: Support annual planning, budget planning, long-range Medical Affairs operational strategy, pipeline expansion, and new product launch readiness. Develop resource and infrastructure plans that enable growth across regions, functions, and therapeutic areas.

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field required.
• Advanced degree (MS, MBA, MPH, PharmD, or equivalent) preferred.

• 10+ years of experience in Medical Affairs Operations, Clinical Operations, Commercial Operations, or related pharmaceutical/biotech functions.
• Minimum 5 years of people management experience.
• Oncology experience strongly preferred.
• Experience supporting both US and international Medical Affairs organizations preferred.
• Demonstrated experience supporting pre-launch and launch-stage organizations.
• Proven experience managing complex vendor relationships, operational budgets, and cross-functional initiatives.

• Strong leadership and team development capabilities.
• Excellent project and portfolio management skills.
• Deep understanding of healthcare compliance requirements, FMV processes, Sunshine Act reporting, and contracting practices.
• Strong financial and budget management expertise.
• Ability to operate effectively in a fast-paced, matrixed biotech environment.
• Experience implementing operational systems, dashboards, and process improvement initiatives.
• Strong analytical and problem-solving skills with a focus on operational excellence.