Head of Medical Affairs Operations & Excellence

Responsibilities

• Lead the design, implementation, and continuous improvement of Medical Affairs operational models across North America
• Translate Medical Affairs strategy into integrated operational plans, timelines, and execution frameworks
• Oversee North America Medical Affairs operating budgets, including planning, forecasting, and tracking
• Oversee a team of Medical Affairs project managers responsible for key initiatives and milestones
• Establish standardized project management methodologies, tools, and best practices
• Lead Medical Affairs governance forums and operating rhythms
• Define and implement performance metrics, dashboards, and reporting to track execution and impact
• Partner with Clinical Development, HEOR, Regulatory Affairs, Commercial, Finance, Legal, and Compliance

Requirements

• Bachelor's degree in Life Sciences, Business Administration, Project Management, or related field
• Advanced degree (MD, PharmD, PhD, MSN) strongly preferred
• Minimum 12 years in pharmaceutical/biotechnology industry
• At least 6 years within Medical Affairs
• Demonstrated leadership in Medical Affairs Operations or strategic planning
• Proven success leading project managers or operational teams
• Knowledge of evidence generation activities (ISS, medical publications, RWE)
• Strong understanding of clinical development processes and regulatory requirements

Preferred Qualifications

• Advanced scientific or clinical degree
• Experience in a complex matrix environment
• Expertise in portfolio management and resource planning

About the Company

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in bone and mineral, intractable hematologic, hematology oncology, and rare disease areas.