Senior Director, Clinical Outsourcing

Senior Director Of Clinical Outsourcing

At Eisai, our mission is to satisfy unmet medical needs and increase the benefits healthcare provides to patients, their families, and caregivers. We are a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role is accountable for designing and executing sourcing strategies that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH / GCP guidelines and local regulations, ensuring inspection readiness and adherence to corporate standards.

As a key influencer, the position drives preferred vendor strategies, negotiates complex agreements, and fosters strong partnerships with CROs and strategic suppliers. The role also leads process excellence initiatives, competency development programs, and functional maturity assessments to embed best practices across the organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance, IT Security, and Clinical teams to align outsourcing strategies with broader corporate objectives.

This position requires a seasoned leader with deep expertise in strategic sourcing, vendor governance, and clinical operations within a pharmaceutical environment. Strong communication skills, executive presence, and proficiency with enterprise systems are essential, along with a proven track record in inspection-facing roles and global regulatory compliance.

Essential Functions

Clinical Outsourcing

• Designs and executes outsourcing strategies that deliver cost efficiencies, elevate vendor performance, and reduce potential risks.
• Oversees vendor qualification and collaborates with Vendor Risk Assessment teams to ensure vendor strategies comply with regulatory standards and align with overall corporate objectives.
• Leverages extensive knowledge of strategic sourcing best practices to guide and lead teams toward achieving business goals.
• Oversees Outsourcing function's adherence to ICH / GCP guidelines, local regulatory requirements, and SOPs / SWPs on a global basis.
• Participates in external events to present Eisai capabilities or capture industry knowledge.

CRO / Vendor Management

Clinical Trial Support

Problem Solving

Process Management

Coordination and Collaboration

Requirements