Clinical Supply Manager

Responsibilities

• Define the supply strategy for clinical study investigational medicinal product (IMP) in alignment with study protocols.
• Forecast IMP demand for global studies and create, monitor, and adapt supply plans to meet clinical study demand.
• Represent the Clinical Supply Chain on Clinical Study Teams (CST) and collaborate with Clinical Operations, Regulatory, Quality, and CMC.
• Oversee IMP shipments within the global distribution network and manage documentation for import/export to depots and study sites.
• Manage vendors for labeling, packaging, distribution operations, and supporting services.
• Manage comparator sourcing activities to ensure uninterrupted supply for clinical studies.
• Support IRT design for drug modules, perform user acceptance testing, and oversee ongoing supply activities in the system.
• Coordinate drug returns from sites to depots and perform study drug reconciliation at study closeout.
• Lead cross-functional projects and process improvements related to drug supply, including the creation of Standard Operating Procedures (SOPs).

Requirements

• Bachelor’s or Master’s degree in Business Administration, Operations Management, or a related field.
• Minimum of 5 years of progressive supply chain experience, preferably within the biotech, pharmaceutical, or CRO industry.
• Proven experience with Phase 3 Global study start-ups.
• Direct experience with Comparator Sourcing.
• Hands-on experience with IRT systems.
• Working knowledge of Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP).

Benefits

• Competitive base salary ($110,000 - $135,000 USD).
• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.
• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off and paid holidays.

About the Company

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. We are currently advancing a lead product candidate, atacicept, and evaluating several other high-potential therapeutic programs.