Bicara Therapeutics

Director

• Provide strategic and scientific leadership for the Analytical Sciences function, ensuring scientific excellence and regulatory compliance.
• Lead late-stage analytical development, method transfer, qualification, validation, and commercial testing strategy.
• Oversee pivotal BLA-enabling analytical development deliverables for late-stage programs.
• Provide technical guidance during investigations at CMOs/CROs and review technical development documents.
• Define and justify commercial control strategies, specifications, and acceptance criteria for complex modalities.
• Develop and defend comparability strategies for process changes, scale-up, PPQ support, and post-approval changes, including structure–function correlation.
• Lead, mentor and develop high-performing analytical sciences teams.
• Provide analytical input and leadership for regulatory filings and responses to health authority questions.
• 20-25% travel in support of manufacturing and development activities at CDMOs.
• Collaborate with cross-functional teams, including process development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and success.

Senior Director, Analytical Sciences

Communications

• Execute integrated communications strategies supporting Bicara’s pipeline and disease-area leadership.
• Partner with functional leaders to drive proactive media relations, product storytelling, and disease awareness campaigns.
• Support disclosure planning for major milestones, including clinical data readouts, regulatory events, and key conference participation.
• Support digital and social strategy across platforms, ensuring consistent tone and message alignment with corporate objectives.
• Serve as a senior advisor on financial and scientific communications for the executive team.
• Support the development of quarterly earnings materials, including financial primers, management scripts, investor decks, and Q&A preparation.
• Maintain relationships with the investment community and sell-side analysts; support conference and investor meeting preparation.
• Manage shareholder and peer analyses, investor targeting, and consensus model reporting.
• Lead cross-functional competitive intelligence processes to synthesize market, pipeline, and peer insights—partnering with Clinical Development, Medical Affairs, Commercial, and Corporate Strategy teams to ensure external messaging, investor engagement, and development strategy are informed by current industry dynamics.
• Collaborate with Finance, Accounting, Legal, Medical Affairs, Development, and other functional partners to ensure scientific accuracy and accessibility of external communications, and alignment across disclosures, messaging, and compliance.
• Partner with the People team to promote transparency, reinforce company culture, and ensure employees are informed ambassadors of Bicara.

Director, Investor Relations and Corporate Communications

Clinical Research

• Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.
• Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
• Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
• Work closely with external collaboration partners with a focus on relationship management and efficiency.
• Lead the proactive identification, assessment, and management of clinical study challenges and risks.
• Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.
• Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
• Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
• Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.
• Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study.
• Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.
• Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
• Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.

Senior Clinical Trial Manager

• Lead and manage statistical programming activities for clinical studies, ensuring high-quality deliverables and adherence to established timelines.
• Allocate resources effectively and promote resource sharing across programs to meet organizational goals.
• Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements, ensuring alignment with overall clinical and regulatory objectives.
• Develop, validate, and maintain analysis datasets in compliance with CDISC standards, as well as tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards.
• Review Statistical Analysis Plans (SAPs) to provide feedback, technical input, and strategic recommendations for successful execution.
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA, PMDA), ensuring compliance with eCTD and electronic submission standards.
• Build and maintain software-agnostic solutions and macros to automate repetitive tasks and improve programming efficiency.
• Manage, mentor, and guide junior programmers, fostering their professional growth and ensuring consistent quality across deliverables.
• Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis to enhance team capabilities and process efficiency.

Senior Director, Statistical Programming

• Serve as the lead statistician for assigned oncology programs and studies.
• Partner cross-functionally with Clinical, Regulatory, Medical, Statistical Programming, and Data Management teams to define and execute statistical strategies aligned with development objectives.
• Provide statistical input to clinical protocols, SAPs, CRFs, and data management plans; oversee execution of analyses and reporting deliverables.
• Perform or oversee statistical analyses using SAS and/or R, ensuring scientific rigor and reproducibility.
• Manage and oversee deliverables from CROs and external vendors, providing statistical review, feedback, and quality control.
• Contributes to the design and implementation of innovative statistical methodologies to enhance the efficiency and interpretability of oncology studies.
• Promote statistical literacy across cross-functional teams, helping colleagues understand key concepts and data-driven insights.
• Support the development of publications, abstracts, and presentations through data interpretation and statistical input.

Associate Director, Biostatistics

• Review and manage DM activities in vendor proposals and budgets
• Function as internal DM Study lead, overseeing data management activities performed by CROs
• Review and manage key documents such as data management plan and CRF completion guidelines
• Provide DM level review on all study medical coding
• Oversee eCRF design and annotation, database design specifications
• Participate in user acceptance testing (UAT) of the clinical database
• Lead internal study team in data review
• Define/oversee data transfer specifications for external data sources
• Collaborate with SAS and clinical systems programming to produce data reports
• Mentor other data management personnel.

Senior Director, Analytical Sciences

Director, Investor Relations and Corporate Communications

Senior Clinical Trial Manager

Senior Director, Statistical Programming

Associate Director, Biostatistics

Associate Director, Clinical Data Management