Associate Director, Clinical Supply Chain Operations

Location
South San Francisco, CA
Posted
Oct 05, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

ASSOCIATE DIRECTOR, CLINICAL SUPPLY CHAIN OPERATIONS

Position Summary:

This position will lead and oversee Clinical Supply Chain Operations activities, consisting of global packaging, labeling and distribution processes, in support of Global Blood Therapeutics, Inc (GBT) development programs.

 The scope of activities includes management and oversight of Contract Manufacturing/Packaging operations, management of the clinical labeling processes, set up of distribution and logistics networks and related processes.  The incumbent will successfully interface with internal and external collaborators to execute on clinical supply strategies.

Essential Duties and Responsibilities:

  • Packaging and Labeling – Manage and oversee global portfolio of GBT contract clinical packaging operations. Develop processes and procedures to ensure adherence to supply plans
  • Accountable for on-time Investigational Medicinal Product (IMP) releases for distribution
  • Develop and maintain internal related standard operating procedures (SOP's)
  • Manage packaging and project schedules with CMO's
  • Collaborate with Manufacturing, QA and other relevant departments in ensuring availability of drug product to execute packaging strategies
  • Closely collaborate with Supply Chain Planning and manufacturing teams on IMP shelf life management and required shelf life extensions
  • Distribution – Develop and maintain internal processes for distribution requirements for all applicable geographical regions
  • Establish global distribution networks based on study requirements
  • Work with logistics carriers, packaging and distribution facilities and regional depots as applicable to ensure timely shipment processing
  • Determine required Import/Export documentation required for IMP and applicable ancillary items per country/geographical region
  • Collaborate with Clinical Operations, Regulatory Affairs, and respective Clinical Research Organizations (CROs) as required to maintain documentation requirements and ensure relevant documents are available to execute shipments
  • Work with vendors to establish sound IMP return processes and collaborate with study managers on clinical study returns
  • Quality Processes – responsible for relevant Quality documentation as change controls, deviations, CAPA's, as they relate to packaging and distribution processes
  • Qualified Person (QP) processes – collaborate with Manufacturing, Quality and Regulatory Affairs to obtain any required documentation (QP declarations/QP releases) to support regulatory submissions and on-going supply
  • Temperature Excursions- collaborate with Clinical Supply Chain study managers and CMC related teams to resolve IMP related temperature excursions
  • Jurisdictional Control processes – Supply Chain owner of Jurisdictional Control process for IMP, interacting with QA and Regulatory Affairs in determining distribution decisions based on available regulatory approvals
  • Financial acumen – develop clinical supply budgets and revisions as required, provide required financial estimates, including financial accrual process
  • Vendor management – effective vendor oversight ensuring project timelines as well as cost and compliance requirements are met.  Develop Request for Proposals (RFP's), collaborate with GBT Legal and Finance groups in reviewing and providing input of Master Services Agreements, contracts, and other relevant documents
  • Develop and track Key Performance Indicators (KPIs) related to vendors processes
  • Regulatory submissions – interact with CMC, QA, Regulatory Affairs, Clinical Operations, and other relevant cross-functional group to support regulatory strategy development and execution
  • Provide input as required on sections related to IMP packaging and labeling
  • Effective cross-functional collaborator, communicator, and influencer.  Interface with GBT's CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required
  • Supply Chain Subject Matter Expert on CMC program meetings and any other functional meetings as required
  • Leading and Mentoring – hire, and mentor staff.  Lead and support process improvement initiatives

Qualifications:

  • BS/BA or MBA degree, with 7+ years of experience in Clinical Supply Chain
  • Typically requires 7+ years of experience in clinical or commercial supply chain management
  • Vendor management experience, specifically with Clinical Packaging and Distribution vendors, with strong negotiation as well as business facilitation skills
  • Working knowledge of cGMP's, familiar with US, EU and global regulations applicable to investigational drugs and cGCP regulations applicable to IMP and supply
  • Good organizational and communication skills, effective project and time management skills, and able to work well under pressure. Excellent interpersonal skills
  • Ability to think strategically and translate into actionable plans. Ability to function in a fast and dynamic environment
  • Proficient in Microsoft Office suite utilization.  Project management software (MS Project, Smartsheet) 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
  • Supervisory and mentoring skills a plus


Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company's facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.