Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com .
At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.
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.
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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.