Overview:
Bicara Therapeutics is hiring a Senior Manager to lead global clinical supply chain operations for early- and late-phase oncology trials (Ph1–Ph3), particularly for their lead program Ficerafusp alfa. This new role reports to the Senior Director of Supply Chain and is essential to ensuring timely, compliant delivery of clinical trial materials.
Key Responsibilities:
- Develop and manage end-to-end clinical supply strategies for global trials.
- Collaborate cross-functionally on forecasting, budgeting, and demand planning.
- Oversee vendor management, performance tracking, and cold-chain logistics.
- Handle global distribution, labeling, and packaging of clinical materials.
- Own and manage IRT systems including requirements, testing, and operations.
- Ensure regulatory compliance (cGMP, GCP, GDP) and audit-readiness.
- Author SOPs and maintain trial documentation for inspections and TMF inclusion.
Qualifications:
- Bachelor’s degree in Life Sciences, Supply Chain, or related field; advanced degree preferred.
- 5–8+ years experience in clinical supply chain within biotech/pharma.
- Proven experience across Ph1–Ph3, global, blinded clinical trials.
- Strong background with vendors, cold-chain logistics, IRT systems, and global regulations.
- Knowledge of ERP/supply chain systems (e.g., SAP, Oracle, Kinaxis) is a plus.
- Adaptable and effective in fast-paced, cross-functional settings.
Job sourced from Bicara Therapeutics.