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.

Job Summary

The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual will be able to work independently as well as work collaboratively with cross-functional groups to ensure the most optimal solutions are achieved in alignment with global strategies.

Essential Functions

• Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.
• Accountable for vendor management; providing guidance to study teams on vendor selection and management options in alignment with global strategies.
• Lead the process of Request for Proposal (RFP) development through supplier selection and final contract execution on projects when required.
• Support project teams in the resolution of performance issues if escalated at a regional level.
• Collaborate with functional departments (e.g. business operations, legal, finance etc.) to understand and deliver business requirements.
• Negotiate global Master Service Agreement with preferential business terms and preferred pricing.
• Implement global strategies within the region and provide training and training materials as necessary. Maintain current awareness of clinical outsourcing marketplace and industry trends.
• Participate in supplier oversight and governance meetings and lead processes improvement initiatives as required.
• Report to Director on issues and global strategies.
• Manage, mentor and develop direct reports.

• Ensure efficient use of resources and lead recruitment initiatives as required.
• Accountable for regional outsourcing team deliverables and compliance with global and regional processes.
• Ensure contract tracking systems and databases updated with relevant information by the Outsourcing team in a timely manner.
• Lead and support the qualification and evaluation of new suppliers as required.
• Responsible for global alliance management of identified key service providers and managing service provider business relationships in alignment with global strategies.
• Review and approve Clinical Quality Assurance audit plans and reports.
• Review and respond to internal audits and corrective action plans as necessary.
• Establish and maintain relationships with key regional and global stakeholders.
• Ensure outsourcing initiatives are effectively communicated at a regional level.

Requirements

• BA/BS in scientific or business discipline with an advanced degree.
• Minimum 7-10 years procurement experience, minimum 7 years pharmaceutical/clinical outsourcing.
• In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.
• Excellent verbal, written and interpersonal skills and ability to work effectively in a cross-functional team environment.
• A dynamic individual with exceptional leadership, organizational and time management skills.
• Highly analytical with an attention to detail.
• Able to influence senior key stakeholders and build relationships between different functions.
• Capable of develop regional and global processes and supporting documents as necessary.
• Highly proficient in MS Office Suite with a good understanding of other IT systems for contract management and clinical development.

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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 .

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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