Manager/Sr. Manager, Clinical Supply
The Manager/Senior Manager 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 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.
- 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.
- 5+ years of relevant experience in the pharmaceutical or health care industry or equivalent, and a Bachelor’s degree, preferably in a scientific discipline, or
- 2+ years of relevant experience and a Master’s degree
- Direct experience in clinical trial supply activities is required
- 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 Biosciences is an equal opportunity employer.