Manager/Sr. Manager - Clinical Supply

Location
Hayward, CA, United States
Posted
Aug 21, 2020
Ref
129
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
About us:

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.

Overall Description:

The Manager/Senior Manager will provide day to day management of clinical supply products (both investigational and commercial) in support of all Clinical Development Programs. The individual in this role will be responsible for the coordination, procurement, and management of drug product supply and distribution activities for clinical trials. This position will work with both internal and external customers, suppliers, and CROs to assist in development and communication of clinical supply project costs, protocol 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.

Job Duties and Responsibilities:
Responsibilities may include, but are not limited to:
  • Works with internal functions (pre-clinical and clinical) as well as external groups such as CRO, Depot, and Manufacturing companies to execute appropriate supply strategies, project timelines, and project plans to meet study requirements.
  • Coordinates with project team in the pre- project planning phase to define study requirements (documents, drug products, forms and/or ancillary labeling, if required). This includes creating protocol specific Distribution Instructions, Drug Shipment Request templates, and other study documentation, as appropriate. Works with vendors to ensure accurate counts (physical inventory vs. virtual inventory records)
  • Manages and monitors the overall bulk product inventory, ensuring appropriate supplies are ordered, maintained and distributed to clinical sites, based on industry standards and specific project requirements.
  • Coordinates trial supply storage, labeling/packaging, and distribution activities with domestic and international vendors/depots per study supply plans
  • Manages and monitors shipments to clinical sites, e.g. courier tracking, acknowledgement of receipt, cold chain product management (Out of Spec temperature excursions) etc. Oversees logistics for bulk shipments between 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.)
  • Manages PO generation and invoicing approvals for storage and clinical kitting / distribution vendors.
  • Serves as the Supply Chain representative on Clinical Trial Teams and other project teams as assigned.
  • Participates in the set-up of IRT systems (specifications review/UAT) and day-to-day management of IRT (re-supply strategy in IRT/supply inventory).
  • Provides guidance for returns for destruction and performs final IP reconciliation.


Qualifications/Experience/Skills:
  • Bachelor's degree, preferably in a scientific discipline with 5+ years of relevant experience in the pharmaceutical or health care industry or equivalent OR
  • Master's degree with 2+ years of relevant experience
  • Direct experience in clinical trial supply activities is highly desired
  • 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