Director of Medical Affairs Operations

Key Responsibilities

• Provide insights into the development and implementation of the medical affairs strategy to support the successful launch of rare disease products
• Collaborate cross-functionally with clinical, commercial, and regulatory teams to ensure alignment on pre- and post-launch activities
• Partner with senior leaders to develop and execute the Medical Affairs strategy in alignment with organizational objectives
• Drive operational efficiency by streamlining processes, workflows, and systems within Medical Affairs
• Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement
• Develop and maintain governance frameworks to support compliance, quality, and risk management
• Support the Medical Affairs system and technology roadmap to support business objectives of Medical Affairs
• Support the assessment of future technologies for the department and help direct departmental implementation of new technologies
• Partner with IT to ensure project goals are in line with global business plans of action and project plans are tracked
• Partner with Finance to ensure international projects are managed with fiscal discipline and track to budget
• Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement
• Facilitate effective communication and information sharing to drive seamless execution of medical strategies
• Ensure alignment of medical communications with the company's broader scientific and clinical objectives
• Collate actionable MSL field insights to inform medical and commercial strategies
• Help guide the creation of medical education and training materials for internal and external stakeholders
• Oversee the implementation of strategic initiatives, ensuring delivery on time and within scope
• Manage cross-functional project teams to execute high-impact projects that support Medical Affairs priorities
• Create dashboards and reporting systems to track the progress of key initiatives
• Liaison with external vendors and agencies supporting medical communications and publications
• Co-develop performance metrics and provide coaching to optimize MSL impact on scientific exchange and KOL engagement

Qualifications

• Minimum of 7 years of experience in medical affairs leadership within the biopharmaceutical industry, preferably in rare diseases
• Proven leadership experience in medical affairs with successful product launches
• Experience in medical affairs operations including medical communication, and KOL engagement
• Strong leadership and project management experience
• Exceptional communication and interpersonal skills with the ability to influence cross-functional teams
• Deep understanding of rare disease therapeutic areas and related regulatory requirements
• Experience in designing and executing advisory boards, symposia, or investigator-initiated studies
• Familiarity with health economics and outcomes research (HEOR) to support value messaging in rare diseases
• Demonstrated ability to build strong relationships with external stakeholders