Manager, Clinical Drug Supply

Description:

Fate is currently seeking an experienced Clinical Supply Manager to join our Technical Operations team. The successful candidate will be responsible for Investigational Product (IP) supply operations for multiple clinical trials and for managing the IP distribution process. The successful candidate will have excellent organizational and communication skills, supply chain systems experience, a keen attention to detail and thrive in a team environment. This is a full- time position reporting to the Executive Director of Supply Chain and is located at our corporate headquarters in San Diego, California.

Responsibilities:

• Manages IP supply planning and timelines to ensure alignment with overall clinical development plan. Provides input to the development of IP related study documents including protocols, study and pharmacy manuals as needed.
• Coordinates with the Clinical Trial Management Team on planned patient dosing schedule and creates a shipment plan to ensure IP is delivered to the clinic in time.
• Coordinates and manages the cryopreserved dewars and courier shipments to ensure all shipment legs are executed as planned or develop alternate solutions in case of a delay.
• Manages and tracks IP inventory; advises management team of potential shortages and makes recommendations for resupply activities based on usage trends and forecasting; Accountable for all study specific IP released and where/when each unit was used.
• Utilizes Interactive Response Technologies (IRT) systems to manage shipments from depots to clinical sites to patient dosing.
• Sets up IRT parameters for new studies and participates in User Acceptance Testing to ensure the system is functioning correctly to meet the study protocol requirements from a drug supply perspective.
• Reviews drug return and/or destruction and administration records.
• Lead trouble shooting effort for investigational product shipment issues.
• Develop plans for supplying clinical study sites with ancillary supplies.
• Oversees international shipments requiring customs paperwork for worldwide shipment of IP and clinical trial materials.

Qualifications:

• B.S. / B.A. degree and a minimum of 5 years related experience in a clinical stage biotech or pharmaceutical company with a minimum of 3 years of experience in clinical supply management.
• Experience managing and shipping temperature sensitive IP, ideally using LN dewars.
• Experience setting up and using Interactive Response Technologies (IRT) for IP shipments and usage.
• Effective problem-solving skills; Written and verbal communication and presentation skills in small and large group settings; Project management and organizational skills.
• Computer skills, with competency in MS Word and Excel.
• Knowledge of ICH/GCP and regulatory guidelines/directives; Disease/therapeutic area knowledge a plus.
• Must work well in a team environment with admirable interpersonal and communication skills (written and verbal).

Working Conditions and Physical Requirements:

• 100% on-site work at corporate headquarters and research facilities in San Diego, CA
• Occasional evening and weekend work will be required

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.