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Bicara Therapeutics Inc

13 open roles indexed with location, benefit, and apply-link signals where available.

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  • Director, Medical Writing

    Boston, MA, United States

    unspecified Salary not disclosed

    Director, Medical Writing Boston, MA, United States Position Overview Bicara Therapeutics is seeking a proactive and detail-oriented Director, Medical Writing to lead the development of complex, high-quality scientific documents that support our clinical development and regulatory submissions. Reporting to the VP, Regulatory Affairs, the ideal candidate will work closely with regulatory leadership, cross-functional teams and external partners to deliver accurate, clear, and compliant documentation on time. This role is ideal for an experienced Medical Writer who thrives in a small, fast-moving biotech environment. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - Lead the Medical Writing efforts and strategy for clinical and strategic regulatory documents, ensuring high quality and on-time writing deliverables in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs). This includes but is not limited to health authority briefing packages, pediatric plans, designation requests, clinical protocols, investigator brochures, clinical study reports, and IND/BLA summary documents. - Document lead for regulatory document creation, review and approval process. - Works with project team members to develop a plan and timelines for regulatory document initiation and completion. - Partner with cross-functional leads to interpret and present nonclinical and/or clinical data in documents for regulatory submission. - Contributes to documents for regulatory submission in accordance with applicable regulatory guidelines. - Coordinates and drives the adjudication of review comments with other authors and reviewers and provides timely follow-up to address outstanding queries or comments until resolution.

  • Senior Project Manager, Clinical Operations

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Project Manager, Clinical Operations Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Project Manager to provide project management expertise and strong operational support and leadership to the team. The role is highly cross-functional with key interactions with internal and external stakeholders. In partnership with the Clinical Operations Team, the Project Manager will assist in developing integrated plans and will understand developing strategy, identifying critical path activities and determining risks / mitigation plans. The successful candidate will have strong communication skills. They will be highly organized, detail oriented, comfortable with ambiguity, and have a proven track record of managing and driving projects. The role will report to the Senior Director, Clinical Operations. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - Serve as an integral part of the Clinical Operations core team to drive operations efficiently including generating integrated project plans, identifying and tracking key project milestones and metrics, and monitoring budgets, invoices, and accruals. - Provide cross-functional transparency of the clinical trial(s) progress to ensure team is efficiently progressing forward with deliverables, including deliverables from CRO and other partners. - Organize internal and external meetings (development of agendas, minutes, and presentations). - Manage ancillary supplies for clinical trials. - Support risk management including risk assessment, mitigation planning, and internal and external audit preparation and follow-up. - Contribute to development of clinical study plans and manuals, including version tracking and team training. - Provide

  • Clinical Trial Associate (APAC)

    Asia-Pacific (APAC), Singapore

    unspecified Salary not disclosed

    Clinical Trial Associate (APAC) Asia-Pacific (APAC), Singapore Position Overview The Clinical Trial Associate (CTA) at Bicara Therapeutics plays a critical role on the Clinical Operations team by supporting the planning, execution, and management of clinical trials. The CTA will work closely with Clinical Trial Managers (CTMs) and other cross-functional teams to ensure that trials are conducted efficiently, in compliance with regulatory requirements, and in accordance with the study protocol. This position will report to the APAC Clinical Trial Manager, Clinical Operations. This position is remote, with a strong preference for candidates located within the APAC region. Responsibilities - Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities in close collaboration with Clinical Trial Managers and CRO. - Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance across assigned regions and sites. - Proactively identify and escalate operational risks, delays, or quality issues to the Clinical Trial Manager. - Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times. - Facilitate effective communication among study sites, Clinical Trial Managers, and other stakeholders by managing correspondence, coordinating meetings, and distributing study-related information, including preparing agendas, tracking action items, documenting decisions, and following up on outstanding deliverables. - Support the site start-up and activation process, including collection and tracking of essential documents in accordance with the EDP; coordination of EC/RA submissions and approvals; vendor coordination; and follow-up with CRO teams to

  • Senior Director, GxP Quality Management Systems (QMS)

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Director, GxP Quality Management Systems (QMS) Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS), reporting to the VP, Global Quality, to build and lead the company's QMS from the ground up. This hands-on leadership role will establish a scalable, phase-appropriate quality framework that supports all GxP activities while driving speed, operational efficiency, and sustained inspection readiness. As a key member of the Quality leadership team, this individual will partner closely with GMP and GCP Quality leaders to design and implement pragmatic, risk-based processes and a fit-for-purpose operating model. The role is accountable for establishing robust systems, governance, and tools that support effective execution, while preserving the agility required to scale alongside organizational growth across clinical and commercial activities. This role is ideal for a leader who excels in a fast-paced, build-mode environment, balancing strategic vision with hands-on execution. The successful candidate brings a collaborative, solutions-oriented approach to partnering across Quality and cross-functional teams and will embed quality into the company's operating model-fostering accountability, simplicity, and continuous improvement as the organization grows. This role is based in Boston with a hybrid schedule (three days onsite per week); however, a remote schedule may be considered. Responsibilities QMS Leadership - Design, implement, and continuously improve an integrated QMS to support all GxP activities at Bicara - Partner with GMP and GCP Quality leads to build practical, fit-for-purpose processes - Lead the establishment of QMS governance, driving consistent and effective use of quality systems

  • Senior Medical Science Liaison (multiple territories)

    United States

    unspecified Salary not disclosed

    Senior Medical Science Liaison (multiple territories) United States Position Overview The Senior Medical Science Liaison (MSL) role is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. We are building our Field Medical team and are open to hiring in multiple territories for qualified candidates. Responsibilities - Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for the company. - Provides education to the medical community on the company's investigational products and disease areas of focus. - Increases company visibility and enhances professional interaction with current and future oncology leaders. - Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues. - Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed. - Identifies clinical research opportunities that are consistent with company objectives. - Is the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication. - Identifies and communicates key clinical and research insights from oncology leaders to help shape company research. - Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications. - Gathers and disseminates competitive intelligence in a compliant manner. - Takes advantage of opportunities to

  • Senior Director, Field Medical Affairs & US Launch Lead

    United States

    unspecified Salary not disclosed

    Senior Director, Field Medical Affairs & US Launch Lead United States Position Overview Bicara is seeking a strategic and execution-driven Field Medical Affairs Lead to build, lead, and spearhead our field medical organization for medical launch readiness and through our commercial launch. This is a highly visible, cross-functional role that sits at the intersection of science, strategy, and stakeholder engagement. This is a rare opportunity to architect the field medical function from the ground up - defining the MSL model, establishing engagement standards, and leading a high-performing team of Medical Science Liaisons (MSLs) at a pivotal moment in the company's history. The ideal candidate combines strategic vision with hands-on field leadership, bringing deep experience in MSL team management, KOL engagement, and launch execution within biotech or specialty pharma. This role is field based and requires the ability to travel up to 60-70% within assigned territory. Responsibilities Field Organization Leadership - Recruit, onboard, train, and lead a national team of Medical Science Liaisons (MSLs), building a field medical function calibrated for launch readiness. - Define and implement the field medical operating model, including territory design, call planning frameworks, engagement metrics, and performance standards. - Serve as a player-coach, maintaining a personal portfolio of national/academic KOL relationships while guiding the team's strategic engagement plans. - Foster a high-performance, learning-oriented team culture rooted in scientific integrity, compliance, and patient-centricity. Launch Strategy, Readiness & Execution - Co-development and execution of the Medical Affairs Launch Plan with VP Medical affairs, ensuring alignment with commercial, clinical,

  • Senior Director, Regulatory Affairs

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Director, Regulatory Affairs Boston, MA, United States Position Overview Bicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory lead with a core focus on BLA strategy and execution-from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs professionals, providing mentorship and oversight while working in close partnership with the VP to ensure alignment on regulatory direction, agency interactions, and submission timelines. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - 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.

  • Senior Director, IT Business Partner (Commercial, Medical & Patient Engagement)

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Director, IT Business Partner (Commercial, Medical & Patient Engagement) Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Director, IT Business Partner (Commercial, Medical & Patient Engagement) to play a pivotal role in shaping and delivering the company's digital strategy across Medical Affairs, Commercial, and Patient-focused functions. This individual will lead the design and execution of a scalable, compliant, and data-driven technology ecosystem that supports medical operations today and enables Commercial launch readiness. Reporting to the VP of IT and partnering closely with the Commercial, Medical Affairs, Market Access, and Patient Advocacy teams, this role is critical in ensuring that Bicara's digital capabilities are aligned with business strategy, regulatory requirements, and long-term growth objectives. This role forms a critical pillar of the IT Leadership Team, playing a central role in shaping and executing Bicara's future digital ecosystem. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities IT Business Partnership & Strategy - Serve as the primary IT partner to Medical Affairs, Commercial, Market Access, and Patient Advocacy teams, ensuring strong alignment between business priorities and technology solutions. - 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

  • Director, Formulation and Drug Product Development

    Boston, MA, United States

    unspecified Salary not disclosed

    Director, Formulation and Drug Product Development Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Director, Formulation and Drug Product Development who will lead the formulation and process development for complex biologics, with a strong emphasis on bispecifics, and fusion proteins, progressing into pivotal studies and commercial readiness. This role oversees drug product control strategy, process validation, and BLA/MMA submissions. The ideal candidate will bring expertise in late-stage development and establishment of drug product control strategies for bispecifics and fusion proteins including experience with Liguid/Lyo process development strategies, and high concentration formulation development. Responsibilities - Develop drug product development strategies through internal/external partnerships and product integration into drug/device combination products. - Oversee, scale-up, and characterize drug product manufacturing processes, including sterile filtration, filling/finish processes, and lyophilization - Oversee drug product development activities, ensuring successful tech transfer, characterization, and process validation - Serve as a subject matter expert on high concentration formulation development with experience in, control of aggregation, viscosity, and sub-visible particles - Provide technical guidance during investigations at CMOs/CROs and review technical development documents - Develop regulatory strategies and draft regulatory submissions including INDs, IMPDs, BLAs, and MAAs - 20-25% travel in support of manufacturing and development activities at CDMOs. - Collaborate with cross-functional teams, including analytical development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and success. Qualifications - M.S. with 12+ years or a Ph.D. in biochemical engineering, chemical engineering, biochemistry, or pharmaceutical sciences, with at least 8+ years of experience in an

  • Program Manager

    Boston, MA, United States

    unspecified Salary not disclosed

    Program Manager Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Program Manager to provide program and project management expertise and operational leadership to the team. The role is highly cross-functional with key interactions with preclinical, clinical, medical, regulatory, and finance. The Program Manager will assist in developing project plans and budgets, identify critical path activities, and manage risks in conjunction with working teams. The successful candidate will have strong communication skills and understand the drug development process. They will be highly organized, detail-oriented, and comfortable with ambiguity. The role will report to the Associate Director, Program Management. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities • 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. Qualifications • Bachelor's degree required, preferably in life sciences or a related field. Advanced degree (MS, MBA, PhD) a plus. • 4+ years of industry experience, including at least 1 year of program/project management experience in the biotech/pharmaceutical industry. Preference for experience in oncology drug development. • Proficiency

  • Senior Director, Commercial Packaging, Serialization and Global Logistics

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Director, Commercial Packaging, Serialization and Global Logistics Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Director of Global Logistics, Commercial Packaging and Serialization that will play a pivotal role in shaping and executing Bicara's global Supply Chain strategy. This role will have immediate impact on establishment and oversight of our commercial packaging and distribution along with strategy and operational oversight of the end-to-end global logistics across both clinical and commercial supply chain. This position reports to the Senior Vice President, Supply Chain and serves as a key member of the leadership team with close partnership and collaboration with Technical Operations, Clinical Supply, Quality, Regulatory, Commercial, Finance, Legal, and a wide range of global external partners across drug substance, drug product, packaging and commercial distribution. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - Commercial Packaging - 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 Bicara's first BLA submission, such as compliance of container closure systems, adherence to approved labeling as defined in regulatory submissions

  • Senior Manager, Payroll and Equity

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Manager, Payroll and Equity Boston, MA, United States Position Overview Bicara Therapeutics is seeking a proactive and detailed-oriented Senior Manager, Payroll and Equity to join our growing Accounting Team. This individual will report to the Director, Accounting and will be responsible for timely and compliant processing for all US multi-state payroll and equity cycles, including semi-monthly payrolls, special/off-cycle payrolls and equity grants as well as partner with cross-functional teams to support global payroll. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities: - 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

  • Senior Director, GMP Quality Operations & Supplier Quality

    Boston, MA, United States

    unspecified Salary not disclosed

    Senior Director, GMP Quality Operations & Supplier Quality Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Senior Director, GMP Quality & Supplier Quality to provide leadership and oversight of GMP Quality operations supporting external manufacturing, quality control, packaging and labeling, QP release, and global distribution. This role is critical to ensuring sustained inspection readiness as the organization advances through Phase 3, regulatory submission, and commercialization. The position will initially focus on clinical supply through external partners and will play a key role in building scalable Quality processes to support commercial readiness, including batch disposition, QP release, and global supply oversight. Operating within a matrixed global Quality organization, this role requires a balance of strategic leadership and hands-on execution, with strong cross-functional collaboration across Technical Operations, Quality Systems, and external partners. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - 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