ZipRecruiter
Associate Director, Clinical Supply Chain
ZipRecruiter, Foster City, California, United States, 94420
Overview
The Associate Director/Senior Manager will provide leadership and support in the planning, development, and execution of clinical supply chain activities for several clinical studies/programs in various phases. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth. Responsibilities
Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, IRT set-up and distribution activities Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction, and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required) Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations Author cGMP documentation including change controls, deviation reports, and SOPs as required Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies Support the procurement, labeling and distribution of comparators Work collaboratively with CMC, Clinical Operations, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing Manage study closeouts and drug reconciliation at study end Develop and manage clinical supply budget and negotiate contracts with vendors Qualifications
7+ years’ experience in Clinical Supply Chain Management in the biotechnology/pharmaceuticals industry Experience managing contract packaging and labeling organizations Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator) Manage vendor oversight activities and vendor performance to ensure high-quality, cost-effective execution of outsourced clinical supply activities Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements Detailed understanding of regulatory and GMP and GDP requirements for IMP supply and international transportation requirements for pharmaceutical materials Global distribution experience including working with QP, IXRS and regional depots Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient Excellent project management and communication skills 10 to 15% travel may be required (including international travel) Bachelor’s degree required, preferably in a relevant field
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The Associate Director/Senior Manager will provide leadership and support in the planning, development, and execution of clinical supply chain activities for several clinical studies/programs in various phases. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth. Responsibilities
Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, IRT set-up and distribution activities Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction, and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required) Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations Author cGMP documentation including change controls, deviation reports, and SOPs as required Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies Support the procurement, labeling and distribution of comparators Work collaboratively with CMC, Clinical Operations, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing Manage study closeouts and drug reconciliation at study end Develop and manage clinical supply budget and negotiate contracts with vendors Qualifications
7+ years’ experience in Clinical Supply Chain Management in the biotechnology/pharmaceuticals industry Experience managing contract packaging and labeling organizations Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator) Manage vendor oversight activities and vendor performance to ensure high-quality, cost-effective execution of outsourced clinical supply activities Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements Detailed understanding of regulatory and GMP and GDP requirements for IMP supply and international transportation requirements for pharmaceutical materials Global distribution experience including working with QP, IXRS and regional depots Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient Excellent project management and communication skills 10 to 15% travel may be required (including international travel) Bachelor’s degree required, preferably in a relevant field
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