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 Director of Clinical Outsourcing is responsible for leading the development and execution of outsourcing strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and vendor relationships, oversees qualification processes, and implements governance frameworks to support clinical development programs. Acting as a key liaison across internal teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and innovation.

The position requires strong leadership, strategic sourcing expertise, and the ability to influence across functions to align outsourcing activities with broader organizational objectives. Proficiency in enterprise systems and a deep understanding of ICH/GCP guidelines and pharmaceutical operations are essential for success.

Essential Functions

Clinical Outsourcing

• Develops and implements outsourcing strategies that achieve cost efficiencies, improve vendor performance, and minimize risk.

• Manages vendor qualification processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with corporate objectives.

  • Applies strong knowledge of strategic sourcing best practices to support team execution and operational goals. Ensure adherence to ICH/ GCP guidelines, local regulations, and company SOPs/ SWPs within the outsourcing function.

  • Participates in external events to present Eisai capabilities or capture industry knowledge

CRO / Vendor Management

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

• Aligns business and clinical research objectives across multiple CROs/vendors, project teams and departments

• Monitors and assesses vendor portfolio performance against contractual operational deliverables

• Builds and maintains strong relationships with strategic suppliers, support preferred vendor initiatives, and monitor performance at the study and portfolio level.

  • Implements vendor governance processes to ensure effective collaboration between internal stakeholders and external partners.

• Drives successful business negotiations and issue resolution at the relationship level

Clinical Trial Support

• Directs global outsourcing team and oversees collation of documentation to ensure inspection readiness on a regional Provides guidance on outsourcing SOPs and work instructions to internal teams and affiliates.

• Facilitates interactions within study teams and functional management to resolve operational issues

• Interfaces with the Head of Operations to assure outsourcing needs are met

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

• Supports functional strategy execution and risk management initiatives

• Departmental Subject Matter Expert (SME) and may participate as a process owner

• Influences work/ study processes spanning multiple department and geographic regions across Eisai

• Aligns outsourcing activities with clinical research objectives across CROs, vendors, and internal teams.

• Monitors performance and support continuous improvement initiatives to embed operational excellence

Coordination and Collaboration

• Directs global cross-departmental communication for clinical outsourcing

• Implements processes and systems to sustain an effective outsourcing function while ensuring compliance with legal, regulatory, and ethical standards.

• Fosters cross-functional collaboration and knowledge sharing to drive innovation and operational efficiency.

• Partners with Finance, Legal, Regulatory & Compliance, IT Security, and Clinical teams to align outsourcing strategies with broader organizational goals.

• Develops and provide guidance to training and development programs to enhance sourcing capabilities and promote best practices on a global basis.

Requirements

• Minimum 10 years relevant work experience

• BA/MS in relevant field

• Experience in pharmaceutical setting required

• Proven experience managing CRO/vendor relationships and supporting regulatory inspections.

• Proficiency with enterprise systems; familiarity with Ariba, Agiloft, Veeva, and Medidata preferred.

• Strong communication skills and ability to influence across functions.

• Demonstrated leadership and problem-solving capabilities

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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