Bicara Therapeutics

Vice President

• Define and execute the biostatistics and data management strategy, setting clear goals that align with the oncology clinical development objectives
• Provide statistical leadership in the design and execution of clinical trials across the various stages of development, and registrational strategies
• Build a high performing team and build processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio
• Drive innovation in statistical methods, automation, and analytics to improve decision-making and execution speed
• Ensure programming workflows and data management processes support regulatory readiness (application of CDISC, regulatory and internal standards)

Vice President, Biometrics & Data Management

Director

• Lead external partnership evaluations and opportunity assessments
• Responsible for the strategic evaluation and operational execution of partnership opportunities
• Build business cases, opportunity assessments, and strategic rationales for potential partnerships
• Develop pitch decks, asset overviews, and partnering materials
• Collaborate with Clinical Development, Clinical Operations, and other cross-functional partners
• Ensure alignment of alliance management activities with the company's objectives
• Develop and maintain a comprehensive knowledge of each contract and associated contracts
• Support development and execution of long-term strategic plans
• Monitor scientific readouts, regulatory events, competitor activity, and market signals
• Prepare strategic updates, program strategy summaries, and market assessments

Director, Corporate Development – Strategy

Supply Chain

• 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.

Associate Director, Clinical Supply Chain

• Lead clinical pharmacology strategy across all stages of drug development including scientific and operational oversight.
• Drive dose selection and exposure–response strategy using model-informed drug development approaches across all stages of development.
• Lead population PK (PopPK), PK/PD, exposure–response, and disease modeling analyses to inform clinical drug development using model-based approach.
• Design and oversee model-informed drug development (MIDD) strategies using population and statistically based methodologies.
• Author and review Clinical Pharmacology sections of INDs, CSR, IB, BLAs, and global submissions.
• Stay current with global regulatory expectations for biologics to contribute to cross-functional strategy.
• Partner closely with Clinical Development, Biostatistics, Regulatory Affairs, Translational Sciences, and Bioanalytical teams serving as an SME in cross-functional discussions.
• Oversee CROs and external modeling vendors as needed.

Vice President, Biometrics & Data Management

Director, Corporate Development – Strategy

Associate Director, Clinical Supply Chain

Senior Director, Clinical Pharmacology, Pharmacometrics