Associate Director, Clinical Supply

Location
Hayward, California
Posted
Jun 09, 2021
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Job Summary:

The Associate Director will provide day to day management of clinical supply products in support of all Clinical Development Programs.  The individual in this role will be responsible for the global management of drug product supply for Arcus sponsored clinical trials as well as external collaborations. This position will work with both internal and external customers, suppliers, and CMOs to assist in development and communication of clinical supply project budgets, global supply plans, and processes to perform quality project execution, ensuring that all project objectives are met in a timely, efficient and high-quality manner.  This is an in-house position and will report to the Director, Clinical Supply.

Responsibilities:

  • Works with internal functions (pre-clinical, clinical, medical affairs, external alliances) to create appropriate drug supply strategies, timelines, and project plans to meet requirements for Arcus sponsored clinical trials, investigator sponsored trials, and external partnerships/collaborations.
  • Manages and monitors the overall drug product inventory, ensuring appropriate supplies are ordered, maintained and distributed to clinical sites, based on industry standards and specific project requirements.  Works with vendors to ensure accurate counts (physical inventory vs. virtual inventory records).
  • Coordinates with project teams to harmonize global drug supply labeling, including tracking required label updates and implementation according to regulatory timelines by geographic region.
  • Oversees logistics for bulk drug shipments between global contract manufacturing and depot facilities, including managing customs import/export activities.
  • Creates, reviews and modifies SOPs for Clinical Trials supply as well as create templates for use during clinical trials (pharmacy manuals, request forms, excursion forms, etc.)
  • Creates and manages clinical supply budget, tracking spending and accruals
  • Participates in the qualification and selection process for new clinical supply vendors, including contract labeling vendors, depots, transport carriers, and IRT systems.

 Qualifications:

  •  10+ years of relevant experience in the pharmaceutical or health care industry or equivalent, and a Bachelor’s degree, preferably in a scientific discipline, or
  • 7+ years of relevant experience and a Master’s degree
  • Direct experience in clinical trial supply activities is required
  • Good understanding of pharmaceutical compliance regulations, such as GMPs, GCPs, and GDPs
  • Ability to establish priorities and collaborate with the study team, cross functional team members and external partners/vendors
  • Self-motivated, assertive, and able to function independently
  • Strong interpersonal and negotiation skills, as well as verbal and written communication skills
  • Able to develop solutions to a wide range of moderately complex problems
  • Good planning and organizational skills, coupled with strong time management skills
  • Aptitude for working with computer systems to plan and manage supply chain requirements
  • Core understanding of IRT system functionality is highly desired.

  

Arcus Bioscience is an equal opportunity employer.