Contract - Clinical Supply Chain Manager

Location
San Francisco, CA, United States
Posted
Jan 12, 2021
Ref
979
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
CONTRACT - CLINICAL SUPPLY CHAIN MANAGER

Position Summary:

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:

  • Business Relationships - Effective cross-functional collaborator and communicator. Interface with GBT's Clinical Operations, Regulatory Affairs, CMC team, Quality Assurance, groups, and others as required to meet project deliverables. Provide support in protocol review, regulatory filings and contract management
  • 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
  • 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
  • Label text - Develop and manage label text in collaboration with Clinical Operations, Regulatory Affairs, and Clinical Supply Chain Operations following country specific regulatory guidance, coordinate translations and proofing processes
  • Returns - Coordinate, setup and oversee return of study drug programs at contracted vendors.
  • Study Execution - 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
  • 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
  • Initiates any related GMP documentation including Change Controls, deviations, CAPA's


Qualifications

  • BS/BA or MBA degree
  • Typically requires 5+ years of experience in clinical or commercial supply chain management
  • Vendor management experience, specifically with Clinical Research Organizations (CRO's) 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
  • 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 (< 10%)