Vera Therapeutics, Inc.

Vera Therapeutics, Inc.

Clinical Supply Manager

Brisbane, CA

Sponsorship not specified$110k-$135kDetected 9 days ago
GCPOperations ManagementSupply ChainLogisticsInventory ManagementGMPFDA RegulatoryGxPRegulatory Affairs

About the role

  • 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

  • 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.
  • 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.
  • 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.

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.
  • 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.

Compensation

  • Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

Company info

  • Vera Therapeutics was founded in 2016 and is based in Brisbane, California.
  • At Vera, our values are the cornerstone of our culture and guide how we work together every day.
  • 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.
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