Bicara Therapeutics
Overview
Bicara Therapeutics is seeking a Manager - Senior Manager of Clinical Supply Chain to lead clinical supply chain activities in global Ph1 and Ph3 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.
Key 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
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 5-8+ 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.
Familiarity with Enterprise Resource Planning (ERP) or other advanced supply chain planning systems (e.g., Oracle, SAP, Kinaxis) is a significant plus.
Highly adaptable and comfortable working in a fast-paced, cross-functional environment with evolving priorities.
Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. 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.
EEO Statement Equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.
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This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Key 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
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 5-8+ 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.
Familiarity with Enterprise Resource Planning (ERP) or other advanced supply chain planning systems (e.g., Oracle, SAP, Kinaxis) is a significant plus.
Highly adaptable and comfortable working in a fast-paced, cross-functional environment with evolving priorities.
Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. 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.
EEO Statement Equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.
#J-18808-Ljbffr