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 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.
