Clinical Supply Manager

Responsibilities

• Work with Clinical Operations to define the supply strategy for clinical study investigational medicinal product (IMP) in line with the study protocol.
• Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high-level service to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
• Forecast IMP demand for global studies based on clinical study protocol and clinical study plan.
• Collaborate with other members of CMC to ensure on-time delivery of IMP and adequate inventory levels of clinical supplies for the entire duration of the trials.
• Create, monitor, and adapt supply plans to supply clinical study demand.
• Initiate and oversee the generation, proofing, and translation of clinical study labels, as required.
• Oversee IMP shipments within the global distribution network and prepare documentation for import and export of clinical supplies to depots and study sites, as required.
• Coordinate drug returns from site back to depot and perform study drug reconciliation at study closeout.
• Manage vendors for all labeling/packaging, distribution operations, and supporting services for Vera programs.
• Manage comparator sourcing activities to ensure uninterrupted supply for clinical study.
• Support IRT design for drug modules, perform user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
• Maintain audit readiness through eTMF filing and documentation practices.
• Lead cross functional projects and process improvements related to drug supply.
• Creates and/or revise process documents such as Standard Operating Procedures.
• Additional responsibilities as required.

Requirements

• Bachelor's or Master's degree in Business Administration, Operations Management, or a related field required.
• Minimum of 5 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry.
• Working knowledge of Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) is required
• Ph3 Global study start up experience required
• Comparator Sourcing experience required
• Experience with IRT systems required
• Vera Therapeutics Inc. is an equal-opportunity employer.
• For this role, the anticipated base pay range is
• $110,000 - $135,000 USD
• At Vera, base pay is only one part of your total compensation package. The successfu

Additional Information

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics' mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: The Clinical Supply Manager will report to the Senior Director of Clinical Supply Chain and will be responsible for carrying out operational activities of the clinical supply chain including logistics, manufacturing, distribution and inventory management of clinical supplies. Working with third-party packaging suppliers, Regulatory Affairs, Quality Assurance, CMC, and the Clinical Operations team, this position will be responsible for ensuring uninterrupted supply in the clinical trials.

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