Senior Manager, Clinical Supply Chain

Role Summary

Bicara Therapeutics is seeking a Senior Manager of Clinical Supply Chain to lead clinical supply chain activities in global Phase 1 and Phase 3 trials for the lead oncology asset, Ficerafusp alfa. This role reports to the Senior Director, Supply Chain and will be responsible for ensuring that our investigational therapy is delivered safely, efficiently, and compliantly to patients around the world. The ideal candidate is a strategic thinker and an executor who thrives in a fast-paced, cross-functional environment and is passionate about building the systems that bring innovative medicines to patients in need. This role is based in Boston with a hybrid schedule, three in-office days each week.

Responsibilities

• Develop, own, and execute end-to-end clinical supply chain strategies for both early-stage (Phase 1) and late-stage (Phase 3) global oncology trials, ensuring alignment with overall clinical development objectives.
• Create, maintain, and refine detailed supply and demand forecasts for all clinical programs. Collaborate closely with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability while minimizing waste and obsolescence.
• Develop and manage the clinical supply budget, including accurate forecasting for Investigational Medicinal Product (IMP), comparator drugs, ancillary supplies, and all vendor-related costs.
• Drive vendor performance and build strong partnerships through the establishment of key performance indicators (KPIs), the execution of regular business review meetings, and proactive, collaborative issue resolution.
• Oversee the entire lifecycle of all clinical trial materials—including active drug (IMP), placebo, and sourced comparator drugs—from manufacturing release through packaging, labeling, global distribution, site inventory management, and final reconciliation and destruction.
• Manage and ensure the integrity of the cold chain for temperature-sensitive products. This includes leading the investigation and disposition of any temperature excursions in compliance with quality and regulatory standards.
• Coordinate all global distribution activities, including the management of central and regional depots, and ensure full compliance with all international import and export regulations for clinical trial materials.
• Author and approve country-specific label text, oversee packaging and labeling campaigns, and perform thorough review and approval of all clinical supply packaging and labeling batch records at contract vendors.
• Serve as the primary business owner for the Interactive Response Technology (IRT) system. Lead the development of user requirement specifications (URS), direct and execute user acceptance testing (UAT), and provide ongoing oversight of the system's randomization and drug supply management modules for all trials.
• Develop, author, and implement a comprehensive suite of Standard Operating Procedures (SOPs) for all clinical supply chain activities to ensure operational consistency, efficiency, and compliance.
• Ensure adherence to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), and all relevant global regulatory requirements applicable to clinical trial materials.
• Maintain all clinical supply chain documentation (e.g., batch records, shipping documents, accountability logs, temperature data) in a constant state of audit-readiness and for the Trial Master File (TMF). Act as the clinical supply chain Subject Matter Expert (SME) during internal audits and regulatory inspections.

Qualifications

• Required: Bachelor's degree in Life Sciences, Supply Chain Management, Pharmacy, or a closely related field. Preferred: Advanced degree (e.g., MS, PharmD, MBA).
• Required: A minimum of 5-8+ years of experience in clinical supply chain management within the biotechnology or pharmaceutical industry.
• Required: Demonstrated, hands-on experience managing the supply chains for both early-phase (Phase 1/2) and late-phase (Phase 3), global, blinded clinical trials.
• Required: Proven expertise in managing a network of external vendors (CMOs, Packagers, Labelers, Depots).
• Required: Experience with Interactive Response Technology (IRT) systems, including leading the development of specifications (URS), executing User Acceptance Testing (UAT), and managing the system post-launch for complex study designs.
• Required: A thorough understanding of cGMP, GCP, GDP, and global clinical trial regulations, including specific requirements for IMP labeling (e.g., Annex 13), blinding, and international import/export compliance.
• Required: Experience with cold-chain logistics (2-8°C and frozen) for biologics or other temperature-sensitive products.
• Preferred: Familiarity with Enterprise Resource Planning (ERP) or other advanced supply chain planning systems (e.g., Oracle, SAP, Kinaxis).
• Required: Highly adaptable and comfortable working in a fast-paced, cross-functional environment with evolving priorities.