Associate Director, Clinical Supply Chain
Scorpion Therapeutics, California, Missouri, United States, 65018
Role Summary
The Associate Director of Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. Reporting into the Vice President of CMC, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, including packaging, labeling and distribution activities. (On-site in San Diego, CA) Responsibilities
Develop and implement clinical supply strategies and oversee distribution and inventory of clinical trial material to ensure uninterrupted IMP supply to clinical sites and minimize product waste throughout the duration of the clinical trial. Provide strategic direction for clinical supply planning to establish IRT system requirements IRT system specifications and contribute to the cross-functional review and approval of IRT user acceptance testing (UAT). Develop and manage forecasts and inventory strategies; analyze actual spend against projections to support accurate budget forecasting and ensure operations remain within financial targets Collaborate with cross-functional departments to create and approve labeling designs in alignment with regulatory framework. Manage packaging activities at CPO and collaborate with QA team for release. Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records. Oversees distribution and inventory of clinical trial material. Manage drug return, destruction process, and accountability at the depots. Manage logistics and execution of material shipments from CDMOs to depots, testing facilities, and CPOs. Responsible for timely review and approval of third-party vendor invoices, ensuring accuracy, contractual compliance and alignment with financial controls. Collaborate with Quality Assurance team on Quality Events investigations, deviations/CAPA, Batch Record Review and drug disposition as required. Manage expiry date extensions, documentation, and distribution activities. Participate in forecast meetings with Clinical Operations including the preparation of slides and communication of inventory updates and operational strategies. Identify and lead process improvement initiatives. Other duties as deemed necessary. Qualifications
Bachelor’s degree in scientific or pharmaceutical discipline. 8+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management. Inventory management and vendor oversight experience in Phase I-III clinical trials required. Global clinical supply distribution experience required. Experience using data visualization platforms or clinical supply software for management of operational logistics, inventory, and forecasting. Experience managing various products and sample shipping and receiving from and between CDMOs, CPOs, depots. Ability to evaluate clinical study assumptions and providing clinical supply forecasts to support manufacturing plans and budget endorsement. Demonstrated understanding of clinical research protocol requirements and experience developing IRT specifications. Skills
Strong analytical and problem-solving abilities Stakeholder management and cross-functional collaboration Forecasting, budgeting, and financial acumen Regulatory awareness related to labeling and IRT Logistics and operations management in a global clinical supply context Education
Bachelor’s degree in scientific or pharmaceutical discipline Additional Requirements
Location: On-site in San Diego, CA
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The Associate Director of Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. Reporting into the Vice President of CMC, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, including packaging, labeling and distribution activities. (On-site in San Diego, CA) Responsibilities
Develop and implement clinical supply strategies and oversee distribution and inventory of clinical trial material to ensure uninterrupted IMP supply to clinical sites and minimize product waste throughout the duration of the clinical trial. Provide strategic direction for clinical supply planning to establish IRT system requirements IRT system specifications and contribute to the cross-functional review and approval of IRT user acceptance testing (UAT). Develop and manage forecasts and inventory strategies; analyze actual spend against projections to support accurate budget forecasting and ensure operations remain within financial targets Collaborate with cross-functional departments to create and approve labeling designs in alignment with regulatory framework. Manage packaging activities at CPO and collaborate with QA team for release. Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records. Oversees distribution and inventory of clinical trial material. Manage drug return, destruction process, and accountability at the depots. Manage logistics and execution of material shipments from CDMOs to depots, testing facilities, and CPOs. Responsible for timely review and approval of third-party vendor invoices, ensuring accuracy, contractual compliance and alignment with financial controls. Collaborate with Quality Assurance team on Quality Events investigations, deviations/CAPA, Batch Record Review and drug disposition as required. Manage expiry date extensions, documentation, and distribution activities. Participate in forecast meetings with Clinical Operations including the preparation of slides and communication of inventory updates and operational strategies. Identify and lead process improvement initiatives. Other duties as deemed necessary. Qualifications
Bachelor’s degree in scientific or pharmaceutical discipline. 8+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management. Inventory management and vendor oversight experience in Phase I-III clinical trials required. Global clinical supply distribution experience required. Experience using data visualization platforms or clinical supply software for management of operational logistics, inventory, and forecasting. Experience managing various products and sample shipping and receiving from and between CDMOs, CPOs, depots. Ability to evaluate clinical study assumptions and providing clinical supply forecasts to support manufacturing plans and budget endorsement. Demonstrated understanding of clinical research protocol requirements and experience developing IRT specifications. Skills
Strong analytical and problem-solving abilities Stakeholder management and cross-functional collaboration Forecasting, budgeting, and financial acumen Regulatory awareness related to labeling and IRT Logistics and operations management in a global clinical supply context Education
Bachelor’s degree in scientific or pharmaceutical discipline Additional Requirements
Location: On-site in San Diego, CA
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