Associate Director, Clinical Supply Chain

Location
San Francisco, CA, United States
Posted
Jun 14, 2021
Ref
1073
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
ASSOCIATE DIRECTOR, CLINICAL SUPPLY CHAIN

Position Summary:

This position will lead Clinical Supply Chain study management activities necessary to ensure timely and continuous drug supply to global clinical studies supporting multiple development programs for both small and large molecule projects/products. This position will be a key member of the Technical Operations group of Global Blood Therapeutics and will lead a team of Clinical Supply Chain Study Managers. The scope of activities includes oversight of drug demand forecasting, setup of global distribution and logistics networks, establishment of IXRS supply strategies as needed to support study execution and milestones, and development of processes for returns and destruction of clinical supplies.

Essential Duties and Responsibilities:

  • Implement processes and procedures to ensure an effective and compliant clinical supply chain
  • Lead clinical demand forecasting activities - able to translate clinical study synopsis/protocols into actionable drug forecasts
  • Develop Key Performance Indicators for supply chain activities related to providing and maintaining study drug at clinical study sites
  • Supply strategies - partner with other members of the Clinical Supply Chain team to develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence
  • Establish global distribution networks based on study requirements. Partner with other members of the Clinical Supply Chain team to ensure required Import/Export documentation is available and supply shipments are dispatched in time to maintain required study site inventories
  • Inventory Management - manage global depot inventory supporting clinical studies based on required targets and jurisdictional control requirements
  • Label text - partner with other members of the Clinical Supply Chain team to develop and manage the Investigational Product labeling process
  • 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. Ensure that depots managed by Supply Chain are integrated into the IRT and using the system effectively
  • Supply Chain Subject Matter Expert on Study Execution Team (SET) meetings and any other functional meetings as required
  • Effective cross-functional collaborator, communicator and influencer. Interface with GBT's Clinical Operations groups, Regulatory Affairs, Quality Assurance, and others as required
  • Support global regulatory submissions from a Supply Chain perspective
  • Effectively partner with other members of the Supply Chain team in areas of CMC and product supply as necessary
  • Financial acumen - participate in the development of clinical supply budgets and revisions as required


Qualifications:

  • BS/BA or MBA degree
  • 7-12 years' experience
  • Working knowledge of cGMP's as related to small and large molecule activities, familiar with US, EU and global regulations applicable to investigational drugs and GCP regulations applicable to investigational product 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 systems including Microsoft Office suite utilization. Experience with Clinical Demand Planning systems a plus
  • Experience with IRT platforms, for open label as well as blinded studies - defining scope, testing and overall IRT supply management


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.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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