North America Head of Medical Affairs Operations & Excellence

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

The North America Head of Medical Affairs Operations & Excellence is a senior leadership role responsible for advancing the strategic, operational, and organizational effectiveness of the North America Medical Affairs function. With regional accountability and strong partnership across Global Medical Affairs, this leader drives integrated planning, governance, resource optimization, performance management, and execution excellence to support the organization's scientific and business objectives.

The role provides leadership and oversight for Medical Affairs operations and directly manages the North America Medical Affairs Project Management team. As a key member of the Medical Affairs leadership ecosystem, the Head of Medical Affairs Operations & Excellence partners closely with regional and global stakeholders to align priorities, enable cross-functional execution, optimize portfolio delivery, and foster a culture of continuous improvement, scalability, and operational rigor across the organization.

Essential Functions:

Medical Affairs Operations & Strategy Enablement

• 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 across therapeutic areas and assets.
• Partner with North America Medical Affairs leadership to support annual planning, goal setting, prioritization, and resourcing decisions.
• Enable effective execution across the Medical Affairs portfolio by driving clarity of roles, responsibilities, decision rights, and interdependencies.
• Provide regional accountability for North America Medical Affairs systems and tools (e.g., planning, tracking, and performance management platforms), ensuring fit-for-purpose use, alignment with global standards, and continuous optimization.
• Oversee North America Medical Affairs operating budgets, including planning, forecasting, tracking, and optimization of spend in partnership with Finance and Global Medical Affairs counterparts.
• Oversee promotional/non-promotional review process

Project Management & Execution Excellence

• Oversee a team of Medical Affairs project managers responsible for planning and execution of key Medical Affairs initiatives, programs, and milestones.
• Establish standardized project management methodologies, tools, and best practices across Medical Affairs.
• Ensure consistent tracking, reporting, and escalation of risks, dependencies, and execution issues across the portfolio.
• Drive on-time, high-quality delivery of Medical Affairs initiatives through strong governance and disciplined execution.

 Governance, Processes & Ways of Working

• Lead Medical Affairs governance forums and operating rhythms, including portfolio reviews, planning meetings, and leadership updates.
• Establish and maintain clear processes for intake, prioritization, execution, and decision-making across Medical Affairs activities.
• Partner with Regulatory, Legal, Compliance, and other functions to ensure Medical Affairs operations align with internal policies and external requirements.
• Drive simplification and efficiency by identifying and addressing process gaps, redundancies, and operational pain points.

 Performance Management & Insights

• Define and implement performance metrics, dashboards, and reporting to track Medical Affairs execution, impact, and resource utilization.
• Enable data-driven decision-making through clear insights into progress, risks, and outcomes.
• Support continuous improvement by using performance insights to inform planning, prioritization, and operational enhancements.
• People Leadership & Capability Building
• Lead, develop, and mentor a team of Medical Affairs project managers, fostering a culture of accountability, collaboration, and operational excellence.
• Build project management and operational capabilities across the Medical Affairs organizati