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Associate Director, Clinical Supply Chain
4 months ago
About:
We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development stages of our antibody-based radiopharmaceuticals. The Associate Director will serve as the primary point of contact between various departments and external partners involved in ongoing and new clinical studies, including Tech Ops, Clinical Operations, CROs, CMOs, and clinical sites.
Responsibilities:
Lead and oversee clinical supply and logistics activities, encompassing demand forecasting, supply planning, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
Establish and maintain the clinical demand plan through a monthly rolling forecast process, ensuring alignment of supply plans and orders.
Partner with Clinical Operations to assess and choose CRO partners and IRT vendors, evaluating their capabilities to support study execution, including global depot networks and IRT functionality.
Act as the clinical supply lead for assigned program(s), developing and managing the clinical supply plan.
Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to identify and address potential risks to the progression of clinical programs proactively.
Supervise and manage the clinical order management process to guarantee timely delivery of drugs to clinical sites as per the plan.
Act as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites. Collaborate with Quality Assurance to address any quality-related matters. Serve as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
Ensure inventory accuracy by maintaining up-to-date records.
Update expiry dates based on stability data.
Assist in ongoing drug accountability and reconcile end-of-study drug inventory.
Initiate production through reorder points.
Qualifications:
Bachelor's or Master's degree in scientific fields, accompanied by a minimum of 8 years' experience in clinical supply chain and logistics within the biotechnology sector.
Proven track record of establishing, refining, and managing clinical supply chains within the biotechnology industry.
APICS certification is advantageous.
Proficiency in Lean methodologies is desirable.
Familiarity with import and export laws and processes.
Previous successful collaboration with CMOs and CROs.
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