Senior Director, Clinical Outsourcing

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're 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 collaborate 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

• Identifies key supplier categories and recommends and approves appropriate negotiation strategies to optimize value.

• Oversees/builds strong relationships with strategic suppliers, leads preferred vendor strategy, monitor portfolio level performance, and promotes streamlined processes and lessons learned.

• Directs and oversees the implementation of a cross-functional vendor governance framework, ensuring alignment between internal stakeholders and external vendors.

• Establishes global strategies for successful business negotiations and issue resolution at the relationship level across multiple supplier categories.

Clinical Trial Support

• Oversees global outsourcing activities, and collation of documentation to ensure inspection readiness.

• Provides guidance to Eisai affiliated companies in undertaking global outsourcing SOPs and work instructions.

• Oversees departmental interactions within study teams to resolve operational issues.

• Routinely collaborates with the Head of Operations to assure outsourcing needs are met and interfaces with regional site heads within clinical R&D.

Problem Solving

• Proactively identifies and assesses risks, escalates through appropriate channels as needed and develops and implements creative solutions.

• Provides insight and experience to study teams and individuals to resolve complex issues and mitigate risks.

Process Management

• Drives functional strategy and risk management initiatives.

• Develops competency models and designs training and development programs to strengthen sourcing expertise and promote best practices across the organization that measure performance and enhance functional maturity by embedding excellence and industry-leading practices within the function and enterprise-wide.

• Oversees & implements processes and systems required to support sustainable outsourcing function, ensuring adherence to legal, regulatory and ethical standards.

Coordination and Collaboration

• Liaises with leaders of other functional areas to agree on methods of work and lines of communication to improve processes.

• Drives cross-functional collaboration and knowledge sharing to foster innovation and capture operational synergies.

• Works closely with Finance, Legal, CQA, Regulatory & Compliance, IT Security and Clinical teams to align outsourcing strategies with broader company goals.

• Drives alignment of business and clinical research objectives across multiple CROs/vendors, project teams and departments.

Requirements

• Minimum 15 years relevant work experience

• BA/MS in relevant field

• Prior experience in leading sourcing, vendor management or procurement functions

• Demonstrated experience supporting regulatory inspections and serving in inspection-facing roles.

• Proficient with enterprise systems; familiarity with Ariba, Agiloft, Veeva and Medidata is highly desirable.

• Ability to communicate effectively and demonstrate strong leadership presence.

• Experience in pharmaceutical setting required.

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Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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