Director, Medical Information and Medical Operations

Role Summary

Director, Medical Information and Medical Operations leading the planning, processes, systems, and infrastructure for Global Medical Affairs, including vendor management, medical meetings, budget oversight, compliance, and medical information services. Oversees a US-based team of operations and medical information specialists to drive operational efficiency, evidence generation, and cross-functional collaboration, with alignment to International MI for compliant external engagements.

Responsibilities

• Vendor Management: Oversee selection, onboarding, contracting, and performance of vendors supporting publications, grants, field medical engagements, advisory boards, and congress activities.
• Meetings & Events: Plan and execute medical meetings, scientific congresses, advisory boards, symposia, and internal/external field medical engagements; monitor medical metrics, KPIs, and dashboards.
• Systems Oversight: Govern GMA platforms and systems supporting publication planning, grants management, and medical engagement tracking.
• Project Management: Provide operational oversight of vendor-led projects, ensuring milestones, deliverables, and timelines are met.
• Budget & Resource Tracking: Monitor budget allocations, vendor invoices, and resource utilization.
• SOP Alignment & Compliance: Update and maintain GMA SOPs with compliance, ensuring activities meet internal SOPs, regulatory requirements, and industry standards; manage Sunshine Act and global transparency reporting.
• Inspection & Audit Readiness: Support inspection and audit readiness in alignment with global and local compliance standards.
• Digital Innovation: Champion adoption of digital tools and omnichannel medical engagement platforms.
• Medical Information Services: Develop, review, and disseminate accurate medical information for marketed and investigational products; maintain SRDs, FAQs, and scientific resources across the portfolio.
• Inquiry Management: Oversee medical information call center/vendor; ensure high-quality responses and regulatory compliance; support Field Medical Excellence in responding to MSL inquiries.
• Metrics & Insights: Track inquiry metrics and provide actionable insights to Medical Affairs leadership and cross-functional teams to inform strategy and evidence generation.

Qualifications

• Advanced degree in Life Sciences, Business, or related field (MD, PharmD, PhD, MBA, or MSc preferred).
• Experience applying AI/ML technologies to develop innovative models/tools that generate actionable insights (strong plus).
• 10+ years in Medical Operations or related Medical Affairs roles within pharma/biotech; minimum 5 years in management/supervisory role with success in strategic planning and building high-performing teams.
• Proven track record in process optimization, systems implementation, and project management.
• Experience in medical information, scientific communications, and congress operations.
• Strong understanding of compliance frameworks (GxP, PhRMA, EFPIA, IFPMA).
• Proficiency with medical systems (e.g., Veeva Vault, MedComm platforms, publication software).
• In-depth knowledge of ICMJE guidelines, good publication practices, and journal review/selection criteria; strong analytical skills to synthesize data into meaningful communications.
• Excellent stakeholder management and communication skills, with ability to balance strategic priorities and hands-on execution.

Education

• Advanced degree as listed in Qualifications (MD, PharmD, PhD, MBA, MSc preferred).