Associate Director, Clinical Supply Chain

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.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

• 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.

• 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.

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.