Eisai US · 20 hours ago
Director, Clinical Outsourcing
Woodcliff Lake, NJ
Full-time
Onsite
Director/Executive
$203K/yr - $267K/yr
10+ years expEisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. The Director of Clinical Outsourcing will lead the development and execution of outsourcing strategies, manage CRO and vendor relationships, and ensure compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
Strong communication skills and ability to influence across functions
Demonstrated leadership and problem-solving capabilities
Preferred
Familiarity with Ariba, Agiloft, Veeva, and Medidata
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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