Eisai US · 2 days ago
Senior Director, Clinical Outsourcing
Nutley, NJ
Full-time
Onsite
Director/Executive
$224K/yr - $294K/yr
15+ years expEisai US is a growing pharmaceutical company focused on addressing unmet medical needs in neurology and oncology. The Senior Director of Clinical Outsourcing is responsible for providing strategic leadership in global outsourcing and vendor management, ensuring compliance with regulatory standards, and fostering strong partnerships with CROs and suppliers.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1001-5000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP & Head of Office, Government Affairs & Policy
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