Contract - Clinical Supply Chain Manager

Location
San Francisco, CA, United States
Posted
Sep 01, 2020
Ref
882
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
CONTRACT - CLINICAL SUPPLY CHAIN MANAGER

Position Summary:

This position is responsible to manage packaging, labeling and distribution activities to ensure timely and continuous drug supply to global clinical studies. This role will be the Subject Matter Expert in managing activities geared to supply clinical trial material for multi- national clinical studies at various stages of development. Working closely with Clinical Operations, Regulatory Affairs, Technical Operations and GBT's Contract Manufacturing Organizations network, this role will support strategies to ensure clinical and development program goals are met.

Essential Duties and Responsibilities:
  • Packaging - oversee clinical packaging activities, review and approve batch record documentation, coordinate release of drug for clinical use
  • Manage and monitor production/packaging schedules at contract manufacturers
  • Initiates any related GMP documentation including Change Controls, deviations, CAPA's
  • Label text - develop and manage label text following country specific regulatory guidance, coordinate translations and proofing processes. Coordinate with clinical packaging facilities to ensure proper label inventory levels are maintained
  • Distribution and Logistics - set up, manage and monitor global distribution networks based on study requirements. Ensure required Import/Export documentation is available. Manage day-to-day orders of resupplies to sites for studies not supported with an IVR/IWR system
  • Returns - coordinate, setup and oversee return of study drug programs at contracted vendors
  • Systems - Develop any required Interactive Response Technology (IRT) supply strategies, review and provide input on User Requirement Specifications (URS) and participate on User Acceptance Tests (UAT) as required. Request modifications when study plans change, or supply algorithms require modifications
  • Participate in Clinical Study Execution (SET) meetings as Supply Chain Subject Matter Expert on information regarding the global use of study drug in clinical studies as required
  • Inventory Management - manage global depot inventory supporting clinical studies
  • Effective cross-functional collaborator and communicator. Interface with GBT's CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables. Provide support in protocol review, regulatory filings and contract management
  • Financial acumen - manage budgets, negotiate vendor contracts as required
  • Vendor management - effective vendor oversight ensuring timelines are met and aligned with internal study execution timelines. Manage external vendor relationships
  • Procedures - develop and establish Standard Operating Procedures (SOP's) as required, propose opportunities for improvement and identify areas of risk through cross-functional collaboration with various functional departments

Qualifications:
  • BS/BA or MBA degree
  • Vendor management experience, specifically with Clinical Packaging and Distribution vendors
  • Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process
  • Good organizational and communication skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills
  • Customer Service oriented, collaborative and self-starter
  • Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus
  • Typically requires 5+ years of experience in clinical or commercial supply chain management
  • Clinical and/or commercial supply chain, planning or materials management, inventory management, and business process facilitation
  • Experience with supplying global randomized, blinded studies
  • Some travel may be required (