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Posted 10 days ago

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Manager, Clinical Supply Chain (Ancillary Supplies)

San DiegoOn-siteFull-time

AI Summary

Manages the planning, sourcing, forecasting, and global distribution of non-investigational dosing supplies for clinical trials, ensuring uninterrupted patient dosing across global sites.

About this role

The Manager of Ancillary Supplies oversees the planning, sourcing, forecasting, and global distribution of non-investigational dosing supplies required to conduct clinical trials. This role is critical to ensuring investigational products can be administered safely and consistently across global clinical sites. The individual will collaborate with Clinical Operations, CMC, vendors, and clinical sites to ensure the availability of compatible ancillary materials and administration systems, supporting uninterrupted patient dosing.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

  • Collaborate with Clinical Operations and CMC to determine ancillary supply requirements, build demand projections, and maintain trial-level supply plans
  • Work directly with clinical sites and vendors to identify administration systems, infusion supplies, and locally available ancillary materials
  • Support site onboarding by reviewing site-specific supply requirements
  • Evaluate site-specific administration supplies and compare them to approved dosing configurations
  • Establish and manage strategic relationships with global ancillary supply and kitting vendors, including vendor selection, qualification, performance oversight, forecasting, and issue resolution
  • Coordinate procurement activities, manage external vendors, depots, couriers, and oversee import/export documentation
  • Monitor site and depot inventory levels, track shipments, manage product expiration dates, and prevent site stock-outs
  • Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, CMC, and trial management teams to align supply strategies with study milestones
  • Proactively identify supply chain risks, develop mitigation plans, and resolve site delivery issues
  • Establish and maintain relationships with ancillary component suppliers.
  • Support investigations related to ancillary supply deviations, supply shortages, or compatibility concerns.
  • Supports global Phase 1 through Phase 3 clinical studies in oncology and autoimmune diseases.
  • Ensure all supply chain and logistics activities adhere to Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and local regulatory standards.
  • REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

    • Bachelor’s degree in supply chain management, logistics, life sciences, or a related field.
    • 3 to 5+ years of experience managing clinical supply chain logistics in a pharmaceutical, biotech, or CRO environment.
    • Working knowledge of clinical trial lifecycles and regulatory guidelines (ICH/GCP, GMP, FDA).
    • Experience supporting biologics, monoclonal antibodies, ADCs, or protein therapeutics preferred
    • Experience sourcing infusion administration devices and ancillary supplies internationally
    • General knowledge of infusion systems, IV bags, tubing, filters, syringes, and administration devices used in clinical trials.
    • Experience managing third-party logistics providers and clinical supply depots
    • Strong analytical, problem-solving, and multi-tasking skills, alongside effective cross-functional communication and vendor negotiation capabilities

    Skills

    Clinical Supply Chain LogisticsClinical Supply DepotsDemand ForecastingFDA RegulationsFiltersGCPGMPICH GuidelinesImport/export DocumentationInfusion Administration DevicesInventory ManagementIV BagsProduct Expiration TrackingSite OnboardingSyringesThird-party Logistics ManagementTubingVendor Qualification

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