Job Description
Job Description
Title : Clinical Supplies Director
Location : San Francisco, CA
Duration : 12 months
Description :
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; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
Responsible for the oversight of Clinical Supply CMOs.
Responsible for the management of global strategies in IRT systems.
Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
Accountable for initiating, overseeing, and resolving departmental deviations.
Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.
Function 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 any quality-related matters.
Serves as the primary representative / subject matter expert (SME) during all inspections and clinical supply chain audits.
Serve 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.
#TB_PH
#ZR
#PB01
Company Description
Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
Company Description
Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
Clinical Director • San Francisco, CA, US