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.
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.
Qualifications: 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. Vera Therapeutics is committed to fair and equitable
compensation practices and we strive to provide employees with total
compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography,
qualifications, skills, and experience. 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 successful candidate will be eligible for an annual performance incentive
bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various
benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays. Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/ . Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
