$80K — $100K *
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.
• 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 courier shipments and deliveries and manages the courier relationship.
Oversees international shipments requiring customs paperwork for worldwide
shipment of IP and clinical trial materials. Coordinates with international Qualified
Person for release of IP for use.
• Responsible for working within established timelines of IP manufacturing, labeling,
release, distribution and return/destruction, and/or helping to establish these
• Manages and tracks IP inventory; advises management team of potential shortages and
makes recommendations for resupply activities based on usage trends and forecasting.
• Oversees IP shipment orders according to supply plans, or as requested by Clinical Trial
Management team, to ensure timely and compliant shipment and delivery to
investigator sites. Works with manufacturing to complete this activity and manages all
aspects of the process.
• Works with cross-functional teams to develop specifications and user testing of
Interactive Response Technologies (IRT) systems provided by 3rd party vendors. Leads
effort for clinical supply management functionality; Monitors and manages clinical
supply activities through IRT from study start-up through study closure; Ensures
appropriate system documentation is transferred to TMF and inspection readiness as
• Participates in domestic and international shipping qualification and validation studies.
• Reviews drug return and destruction and administration records.
• Leads trouble shooting effort for investigational product shipment issues.
• Develops plans for supplying clinical study sites with ancillary supplies, either through
in-house initiated supply or working with supply vendors as needed.
• B.S. / B.A. degree.
• Minimum 5 years related experience in a clinical stage biotech or pharmaceutical
company with a minimum of 3 years of experience in clinical supply management.
• Knowledge and experience with Interactive Response Technologies (IRT) preferred.
• Knowledge of ICH/GCP and regulatory guidelines/directives. Disease/therapeutic area
knowledge a plus.
• Effective problem-solving skills; Written and verbal communication and presentation
skills in small and large group settings; Project management and organizational skills.
• Proficient computer skills, with extensive experience in MS Word and Excel.
• Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC.
• Must work well in a team environment with admirable interpersonal and
communication skills (written and verbal).
Valid through: 4/30/2021
$100K — $150K
14 days ago
$140K — $180K + $15K bonus