Associate Director, Clinical Supply Chain

Bicara Therapeutics•Boston, MA

6d•Hybrid

About The Position

Bicara Therapeutics is seeking an Associate Director, Clinical Supply Chain to lead clinical supply chain activities in global trials for our lead oncology asset, Ficerafusp alfa. This newly created role will report directly 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. We are ideally seeking Massachusetts-based candidates who are able to work a hybrid schedule that includes 3 days per week in our Boston office.

Requirements

A Bachelor's degree in Life Sciences, Supply Chain Management, Pharmacy, or a closely related field is required. An advanced degree (e.g., MS, PharmD, MBA) is preferred.
A minimum of 4-6+ years of experience in clinical supply chain management within the biotechnology or pharmaceutical industry.
Demonstrated, hands-on experience managing the supply chains for both early-phase (Phase 1/2) and late-phase (Phase 3), global, blinded clinical trials.
Proven expertise in managing a network of external vendors (CMOs, Packagers, Labelers, Depots).
Experience with Interactive Response Technology (IRT) systems. This must include leading the development of specifications (URS), executing User Acceptance Testing (UAT), and managing the system post-launch for complex study designs.
A thorough and working 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.
Experience with cold-chain logistics (2-8°C and frozen) for biologics or other temperature-sensitive products.
Highly adaptable and comfortable working in a fast-paced, cross-functional environment with evolving priorities

Responsibilities

Develop, own, and execute end-to-end clinical supply chain strategies for both early-stage and late-stage 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.
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.
Manage Interactive Response Technology (IRT) systems. 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 trials.
Develop, author, and implement Standard Operating Procedures (SOPs) for 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.