Senior Director Medical Affairs Operations

Job description:

Summary of Position

The Senior Director Medical Affairs Operations is responsible for establishing and leading the Medical Affairs Operations function. This role ensures that Medical Affairs strategies are executed effectively, compliantly, and with operational excellence. The incumbent will oversee strategic planning, budget and resource management, medical governance, systems and processes, and cross-functional alignment to drive the success of the Medical Affairs organization.

Work Schedule:
Monday - Friday 8am-5pm

Essential Functions

• Strategic Operations Leadership:
• Partner with the Head of Medical Affairs to define and execute the operational strategy supporting corporate and medical objectives.
• Drive alignment of global, regional, and local Medical Affairs activities through effective governance and communication frameworks.
• Build strong partnerships with key cross-functional stakeholders including Clinical Development, Commercial, Regulatory, and Communications.
• Coordinate Medical Affairs functions—such as Medical Information, Medical Communications, Medical Education, and Project Management—to ensure alignment, efficiency, and synergy.
• Business Planning & Performance Management:
• Lead Medical Affairs strategic planning, launch readiness planning, annual operating plans, and long-range forecasts.
• Develop and manage Medical Affairs budgets, resource allocation, and KPIs to track and report performance.
• Provide insights and recommendations to optimize impact, efficiency, and resource utilization.
• Medical Governance & Compliance:
• Oversee medical governance processes to ensure compliant execution of Medical Affairs activities in alignment with SOPs, regulatory requirements, and industry standards.
• Partner with Compliance, Legal, and Regulatory Affairs to manage risk and uphold the highest ethical standards.
• Operational Excellence & Systems:
• Drive implementation and continuous improvement of systems, processes, and tools supporting Medical Affairs (e.g., medical information, medical insights, evidence generation, external engagement).
• Foster innovation and digital transformation to enhance operational effectiveness.
• Team Leadership & Collaboration:
• Build, lead, and mentor a high-performing Medical Affairs Operations team.
• Act as a trusted partner and operational lead to therapeutic area heads, field medical leadership, Medical Affairs functional leads, and cross-functional stakeholders (R&D, Commercial, Market Access, etc.).
• Champion a culture of collaboration, accountability, and performance excellence.

Requirements

• Advanced degree in life sciences, medicine, pharmacy, or related field; MBA or equivalent strongly preferred.
• 15 or more years of relevant work experience, with 12+ years of experience in the pharmaceutical/biotech industry, with significant experience in Medical Affairs.
• 7 or more years of proven leadership in operations.
• Strong track record in strategic planning, budget management, and operational excellence.
• Deep understanding of medical governance, compliance, and global regulatory requirements.
• Exceptional leadership, communication, and stakeholder management skills.
• Demonstrated ability to drive change, manage complexity, and lead global/matrix teams.
• Oncology experience and strategic consulting experience strongly preferred.

Working Conditions:

• This position will work in typical office conditions with extensive time using personal computer equipment.
• May be required to sit or stand for long periods of time while performing duties.
• Close attention to detail required.
• Willingness to work in a team-based environment.
• The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.
• Ability to travel domestically and potentially Internationally as required.