TalentBurst
Title: Clinical Supplies Director
Location: San Francisco, CA
Duration: 12 months
Responsibilities
Oversee clinical supply activities, encompassing label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
Facilitate timely startup of new studies through prompt supply availability.
Manage the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluate drug utilization versus forecast, considering country requirements and logistical timelines.
Oversee Clinical Supply CMOs.
Manage global strategies in IRT systems.
Create, periodically review, and maintain all Clinical Supply SOPs.
Initiate, oversee, and resolve departmental deviations.
Collaborate with cross‑functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of the Clinical Supply strategy and proactively identify and address potential risks to the progression of clinical programs.
Serve as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots; collaborate with Quality Assurance to address quality‑related matters.
Act as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.
Act as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
Assist in ongoing drug accountability and reconcile end‑of‑study drug inventory.
Provide clinical supply and risk mitigation recommendations.
Oversee inventory management of study drug and comparators at depots.
Mentor CSC team members as needed on programs and systems.
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Location: San Francisco, CA
Duration: 12 months
Responsibilities
Oversee clinical supply activities, encompassing label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
Facilitate timely startup of new studies through prompt supply availability.
Manage the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluate drug utilization versus forecast, considering country requirements and logistical timelines.
Oversee Clinical Supply CMOs.
Manage global strategies in IRT systems.
Create, periodically review, and maintain all Clinical Supply SOPs.
Initiate, oversee, and resolve departmental deviations.
Collaborate with cross‑functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of the Clinical Supply strategy and proactively identify and address potential risks to the progression of clinical programs.
Serve as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots; collaborate with Quality Assurance to address quality‑related matters.
Act as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.
Act as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
Assist in ongoing drug accountability and reconcile end‑of‑study drug inventory.
Provide clinical supply and risk mitigation recommendations.
Oversee inventory management of study drug and comparators at depots.
Mentor CSC team members as needed on programs and systems.
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