Bicara Therapeutics

Compliance

• Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affairs.
• Serve as the global regulatory lead on assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial).
• Lead the planning, preparation, and submission of high-quality regulatory documents to FDA, including INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, and NDA/BLAs. Collaborate with external vendors for submissions in other regions.
• Plan, prepare, and lead health authority interactions, including pre-IND, Type B/C, EOP, and pre-submission meetings; coach and prepare cross-functional teams for successful engagements.
• Lead and manage a small US team of regulatory professionals; set priorities, allocate work, and cultivate a collaborative, accountable team culture.
• Anticipate regulatory risks across regions and proactively design mitigation strategies; advise on regulatory implications of program decisions.
• Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies (e.g., Project Optimus, accelerated approval reform), and translate them into actionable strategy.
• Partner with external collaborators, CROs, regulatory consultants, and co-development partners to ensure aligned, efficient execution of global regulatory plans.
• Ensure compliance with applicable global regulations and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness.

Senior Director, Regulatory Affairs

Director

• Serve as the primary IT partner to Medical Affairs, Commercial, Market Access, and Patient Advocacy teams
• Translate business strategy into a clear, phased digital roadmap spanning Medical through Commercial launch and beyond
• Partner with senior leadership to shape launch readiness strategy, ensuring systems and data decisions are scalable and fit for commercialization
• Contribute to cross-functional planning and provide strategic input into business and operational decisions
• Oversee external vendors, CROs, and system integrators to ensure successful execution
• Support planning, budgeting, and prioritization processes related to digital and IT investments
• Provide clear, structured communication and updates to leadership on progress, risks, and opportunities
• Lead the design and implementation of a unified digital ecosystem supporting CRM and field engagement (e.g., Veeva CRM), MLR and content management (e.g., PromoMats / MedComms), publications, grants, and medical information systems, patient engagement and support platforms (e.g., hub services, case management), commercial operations systems (e.g., pricing, GTN, contracts, incentive compensation)
• Transition from vendor-managed tools to scalable, sponsor-owned platforms
• Ensure seamless integration across CRM, content, patient systems, and platforms
• Collaborate with IT infrastructure teams to enable digital capabilities for Medical Science Liaisons (MSLs) and future Commercial field teams
• Deliver solutions that support KOL engagement, territory alignment, targeting, and segmentation
• Partner with Medical and Commercial teams to drive adoption, training, and effective use of field systems
• Support Patient Advocacy and Market Access teams through implementation of systems that enable patient support, and access
• Ensure patient-related systems are compliant with privacy regulations (e.g., HIPAA) and integrated into the broader data ecosystem.
• Enable insights into patient journey, access barriers, and program effectiveness.
• Define and implement a scalable data strategy across Medical, Commercial, and Patient domains.
• Enable data capabilities HCP/KOL master data, field engagement and claims
• Partner with stakeholders to deliver analytics and insights supporting field effectiveness, KOL engagement and commercial decision-making
• Ensure all systems meet applicable regulatory and compliance requirements, including GxP, 21 CFR Part 11, HIPAA, and Sunshine Act reporting.

Senior Director, IT Business Partner – Commercial, Medical & Patient Engagement

• Lead the formulation and process development for complex biologics
• Oversee drug product control strategy, process validation, and BLA/MMA submissions
• Develop drug product development strategies through internal/external partnerships
• Oversee, scale-up, and characterize drug product manufacturing processes
• Ensure successful tech transfer, characterization, and process validation
• Provide technical guidance during investigations at CMOs/CROs
• Develop regulatory strategies and draft regulatory submissions
• Collaborate with cross-functional teams to ensure seamless integration and success
• 20-25% travel in support of manufacturing and development activities

Director, Formulation and Drug Product Development

Program Manager

• Provide program management support for research teams, working groups, and development teams including timelines, budget development, and meeting management.
• Develop and maintain integrated project plans, identify key project milestones, document and track actions and decisions and conduct risk assessments.
• Work closely with internal stakeholders to maintain cross-functional oversight and ensure transparency of project status.
• Support clear communication with team members and stakeholders including senior leadership.
• Foster a sense of inclusion and create a shared sense of purpose.

• Provides strategic leadership, functional oversight and operational oversight during the commercial packager selection process. Oversees the RFP process and packaging partner selection, contracting, qualification and ongoing performance management.
• Ensures that packaging design, artwork implementation, and labeling strategies support regulatory & global compliance requirements while meeting Bicara’s commercial objectives
• Drives all commercial packaging aspects of the future BLA submission and commercial market launches
• Ensures alignment of all packaging components and processes with regulatory filings, specifically the Bicara’s first BLA submission, such as compliance of container closure systems, adherence to approved labeling as defined in regulatory submissions including strict change control and variation management, oversight of packaging validation and process qualification to meet regulatory expectations for commercial launch readiness
• Establishes and maintains robust artwork governance, label control process and change management in collaboration with Regulatory Affairs and Quality to ensure continue alignment with approved filings for BLA and ex-US dossiers
• Drives the design and implementation of tamper-evident, anti-counterfeiting, and patient safety features across all commercial products
• Manages the CMO relationship – meets regularly to monitor performance, manage materials, and ensure adherence to packaging schedule. Manages commercial packaging budget and invoicing.
• Owns the global serialization strategy including system architecture with internal IT and external partners, drives partner integration and governance across a fully outsourced network
• Ensures alignment of serialization capabilities with commercial launch readiness, lifecycle management, and evolving global serialization and track-and-trace regulations
• Oversees selection, contracting, qualification, and performance management of serialization service providers and technology platforms, including integration with external providers for unit-level serialization, aggregation, commissioning and de-commissioning as applicable.
• Establish and maintain serialization SOPs and partner with relevant groups to ensure audit readiness for any regulatory inspections related to traceability, data integrity and supply chain security
• Collaborate cross functionally with IT, Quality, Regulatory and other stakeholders to ensure that Bicara’s serialization strategy supports patient safety, anti-counterfeiting measures, returns management, and uninterrupted commercial supply
• Assume the global functional ownership, strategy and operational oversight for all clinical and commercial cold chain shipments of GMP materials
• Own Bicara’s cold chain strategy and execution, including qualification, validation, monitoring, and operational optimization of shipping lane and systems
• Develop and maintain strong relationships with internal stakeholders and relevant external partners from drug substance, drug product, packaging and distribution nodes within supply chain to ensure successful implementation and oversight of the company’s global logistics strategy
• Partner with internal stakeholders within Finance, Market Access, Quality, IT and others as applicable to lead selection, qualification, contracting and performance management of the US 3PL that will handle Bicara’s fully outsourced Order-to-Cash model for potential commercial launch in the near term future
• Trade compliance and cross border enablement: ensure that all supply chain activities comply with global export/import regulations and customs requirements, enabling compliant cross-border movement of GMP materials across both clinical and commercial supply chain
• Oversee integration of trade compliance into Bicara’s outsourced operations, including product classification, valuation, and country-of-origin determination, import-export licensing, customs brokerage oversight and regulatory agency engagement, duty optimization strategies in partnership with relevant functions.
• Operate as a cross-functional enterprise leader with accountability for outcomes across Bicara’s outsourced network and internal stakeholders
• Balance strategic design with hands-on operational oversight, stepping into tactical issues when required to protect supply continuity
• Demonstrates ability to influence without direct-line management authority across internal and external ecosystem
• Treat external partners (3PL, CMOs, CPOs, Serialization) as extension of the enterprise supply chain rather than just transactional suppliers
• Align supply chain decisions with broader enterprise priorities while translating complex supply chain dependencies into clear business trade-offs for executive stakeholders
• Actively contributes to Bicara’s BLA readiness planning from a supply chain perspective, ensuring that packaging, serialization, and logistics requirements are fully integrated into the company’s regulatory submission and commercial launch strategy

Senior Director, Commercial Packaging, Serialization, Global Logistics

Payroll

• Own end-to-end processing for semi-monthly and/or bi-weekly payroll across all U.S. states, including exempt and non-exempt employees.
• Prepare and process special payrolls, including stock option exercises.
• Maintain compliance with state and local tax registrations, withholding requirements, SUI rates, and year-end filings (W-2, ACA).
• Maintain payroll system accuracy, including earnings codes, deductions, tax configurations, and pay rules.
• Own year-end payroll activities, including review of forms 3921/3922, W-2, as well as fringe benefit reporting, 401k limits, and ensuring accuracy of state tax rates.
• Partner with HR and Finance to ensure accurate new hire setup, terminations, leave of absence pay, equity income, and bonus processing.
• Manage multi-state nexus tracking and proactively flag new jurisdictional obligations as headcount expands.
• Review and approve monthly EOR invoices; reconcile EOR payroll registers against HR records and Finance cost centers.
• Oversee payroll tax filings, payments, corrections, and resolve tax issues.
• Review payroll for non-US employees.
• Partner with legal, tax, and Finance to assess entity readiness, payroll vendor selection, and local statutory requirements.
• Document payroll procedures, approval workflows, and data flows for each new hub; create scalable runbooks.
• Manage and optimize ADP drive continuous improvement initiatives.
• Produce accurate payroll funding requests, journal entries, and accruals for the Finance team on a timely basis.
• Build and maintain payroll dashboards and audit reports; lead internal and external payroll audits.
• Enforce and document strong internal controls around payroll data access, approval authority, and change management.
• As we continue to grow, act as project manager for payroll system integrations (HRIS, GL, expense).

Senior Manager, Payroll and Equity

Operations

• Provide end-to-end Quality oversight of CDMOs, contract laboratories, and packaging/labeling vendors supporting clinical and future commercial supply.
• Lead supplier qualification, performance management, and establishment of robust Quality Agreements.
• Ensure effective oversight and timely resolution of deviations, investigations, CAPAs, and change controls across external partners.
• Establish and implement scalable, end-to-end batch disposition processes aligned with global regulatory expectations.
• Build and operationalize QP release frameworks in collaboration with EU Qualified Persons and external manufacturers.
• Partner with Technical Operations and CDMOs to support PPQ readiness and execution, ensuring alignment on Quality expectations.
• Contribute to the development and maturation of the commercial manufacturing and distribution model, including supply chain readiness.
• Lead and support inspection readiness activities, including preparation for regulatory inspections across FDA, EMA, PMDA, and other global authorities.
• Partner with Quality Systems to ensure external manufacturing processes are fully integrated into core QMS elements, including deviations, CAPA, change control, and product complaints.
• Develop and implement scalable, phase-appropriate Quality processes to support transition from clinical to commercial operations.

Senior Director, GMP Operations, Supplier Quality

• Perform cumulative safety data reviews across trials or indications to assess safety profiles and identify emerging risks or trends
• Responsible for review of aggregate safety data and signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
• Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)
• Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to applicable health authorities
• Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
• Contribute or be the primary safety contact person for clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup
• Mentor new team members by providing training on core safety processes and fostering their development within the organization
• Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation
• Lead the safety governance meetings and develop meeting materials (agenda, minutes, slide preparation)
• Additional activities as assigned at the discretion of the hiring manager

Associate Director, Safety Scientist

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

• 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.