Bicara Therapeutics

Communications

• Lead the development and execution of global scientific communication plans across key assets.
• Oversee the end-to-end development of manuscripts, abstracts, posters, oral presentations, and digital publication extenders for high-impact peer-reviewed journals and major scientific congresses.
• Facilitate author and internal reviews, including navigating the Medical-Legal-Regulatory (MLR) approval process, while ensuring strict compliance with GPP2022 and ICMJE guidelines.
• Partner with and manage external scientific communication and medical writing agencies to ensure high-quality deliverables, timeline adherence, and budget optimization.
• Ensure all generated publications and medical deliverables strictly align with the established Scientific Communication Platform (SCP), core lexicon, and broader Medical Affairs strategy set by leadership.
• Partner with internal teams to pull the established scientific narratives through into ongoing Medical Affairs activities, maintaining message consistency across global and regional outputs.
• Assist with development of high-impact medical slide decks, FAQs, training materials, and interactive educational tools to enable effective field-based scientific exchange.

Associate Director, Global Scientific Communications

Medical Director

• Direct the pre-launch, launch, and lifecycle medical strategy for oncology pipeline.
• Bridge different cross functional teams for successful therapeutic adoption.
• Oversee medical education, data generation, and external collaborations to maximize patient impact.
• Co-develop and execute a comprehensive, long-term pre- and peri launch medical plan.
• Translate medical strategy into actionable regional/local launch tactics.
• Lead operationalization of the Medical Launch Readiness Framework.
• Map, establish, and maintain trusted relationships with Tier-1 Oncology Key Opinion Leaders (KOLs).

Executive Director – Medical Affairs Launch Strategy

Director

• Define and execute the strategy for End User Services, digital workplace capabilities, and employee productivity technologies, setting clear goals aligned with business priorities, security, scalability, and user experience.
• Lead helpdesk/service desk, deskside support, endpoint and mobile device services, onboarding/offboarding, and day-to-day employee technology operations.
• Build a high-performing function and establish service processes, SOPs, SLAs, KPIs, knowledge management practices, and governance frameworks to ensure responsiveness, consistency, and continuous improvement.
• Own laptop imaging, hardware lifecycle management, asset tracking, software deployment, patching, and CMDB accuracy to support a secure and scalable operating environment.
• Manage and optimize collaboration and productivity platforms, including Microsoft 365, Teams, SharePoint, Zoom, email and calendaring tools, conferencing technologies, and other employee-facing workplace solutions.
• Administer and enhance conference room, audio/visual, and hybrid-work technologies, ensuring reliable performance and an optimized end user experience.
• Lead the implementation and rollout of enterprise AI platforms and AI-enabled productivity tools, driving adoption across functions through targeted enablement, training, and support.
• Partner with business stakeholders to identify and scale AI use cases for knowledge retrieval, content generation, research, data analysis, spreadsheet work, coding assistance, and workflow automation.
• Develop AI enablement programs, including foundational training, role-based deep dives, office hours, playbooks, prompt libraries, and practical usage guidance tailored to functional needs.
• Partner with infrastructure and security teams to ensure workplace technologies are secure, reliable, and well governed, including identity and access management, SSO/MFA, endpoint security, and vendor risk practices.
• Establish and maintain endpoint monitoring and service health practices to proactively identify and resolve issues, improving the stability and reliability of IT services.
• Drive improvements in self-service, knowledge access, user documentation, and employee training to increase adoption and reduce friction across the digital workplace.
• Oversee workplace technology vendors, MSPs, and strategic partners, including selection, performance management, licensing, and cost optimization.
• Support office expansions, relocations, and workplace technology buildouts, ensuring scalable end-user, conferencing, and AV experiences.
• Serve as a key cross-functional partner, aligning digital workplace strategy with business objectives, compliance expectations, and the needs of a growing biotech organization.

Director, Digital Workplace, Cloud

Vice President

• Embedding a company‑wide culture of quality, accountability, and continuous improvement.
• Acting as a visible, influential leader who models high standards and reinforces quality as a shared responsibility across functions.
• Developing and communicating a holistic Quality strategy that supports the shift from clinical development to commercial that is aligned with the company’s goals.
• Anticipating future regulatory, operational, and market needs and ensuring the Quality function is structured to meet them.
• Building a proactive, risk‑based Quality framework that balances innovation with compliance.
• Deep experience with clinical GCP & commercial GMP operations, including late‑stage development, tech transfer, scale‑up, supply chain quality, lot release, QP requirements and post‑market requirements with global partners.
• Willingness to engage directly in critical tasks, investigations, and decisions—especially in a small, resource‑lean environment.
• Meticulous attention to detail with the ability to dive into technical issues when needed.
• Knowledge of global regulatory frameworks and expectations for commercial biologics products.
• Ensuring effective oversight of CMOs, CROs, and vendors through structured governance, auditing, and performance monitoring.
• Experience managing complex external manufacturing networks.
• Proven track record leading successful regulatory inspections.
• Ability to anticipate agency expectations, remediate gaps, and maintain a continuous state of inspection readiness.
• Accountability for the design, approval, and ongoing health of the company’s quality systems in collaboration with IT.
• Oversight of quality operations, including batch disposition, deviation/investigation management, supplier quality, QP release, and document control.
• Develop and implement quality processes, systems, and performance metrics as appropriate for a fast-growing organization with aggressive clinical development plans and future commercialization vision across potentially multiple indications in oncology.
• Partner closely with Regulatory, Technical Operations, Supply Chain, Clinical Operations, Commercial, Finance, IT, and Legal to ensure full alignment and compliance with relevant local and global regulatory requirements, including GxP and any local regional distribution requirements.
• Ability to build, inspire, and lead a high-performing QA organization.
• Skill in developing scalable teams, mentoring talent, and fostering cross-functional collaboration.
• Own and manage Quality budgets across relevant functions and in alignment CDPs.
• Partner with Finance to support LRP scenario modeling.

Vice President, Quality

Clinical Research

• Execute Bicara’s 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.
• 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 – Global

• Develop and execute U.S. market access strategy for Bicara’s oncology lead asset and portfolio.
• Establish clear value and access vision that aligns clinical differentiation with payer, provider, and patient needs.
• Lead market access planning from pre-launch through commercialization.
• Build and lead a high-performing market access organization, including payer marketing, national accounts, trade and distribution, patient support, pricing, and access operations.
• Develop payer engagement strategies to secure optimal coverage, reimbursement, and formulary positioning.
• Build and manage relationships with commercial payers, Medicare, Medicaid, integrated delivery networks, and specialty pharmacy stakeholders.
• Lead account planning and contract strategy for national and regional payer organizations.
• Anticipate and address reimbursement barriers impacting patient access.
• Lead development of launch pricing strategy and gross-to-net planning.
• Oversee contracting strategies across payers, specialty pharmacies, and distribution partners.
• Partner closely with Finance to model access scenarios, rebate strategies, and forecast implications.
• Ensure compliance with all pricing and government reporting requirements.
• Design and implement optimal specialty distribution and channel strategy.
• Lead selection and management of specialty pharmacies, specialty distributors, and third-party logistics partners.
• Establish channel performance metrics and governance processes.
• Ensure launch readiness across distribution, inventory management, and product access pathways.
• Develop patient support and access programs that reduce barriers to therapy initiation and persistence.
• Oversee hub services, benefits verification, copay assistance, patient assistance programs, and reimbursement support.
• Ensure patient services are scalable, compliant, and aligned with customer needs.
• Partner with Medical Affairs and HEOR to develop evidence generation plans that support payer value propositions.
• Translate clinical and real-world evidence into compelling payer communications.
• Ensure access strategies are informed by evolving evidence, treatment pathways, and stakeholder needs.
• Serve as the commercial lead for market access within launch readiness team and across the organization.
• Partner with Medical Affairs on payer engagement and evidence dissemination strategies.
• Collaborate with Regulatory and Legal to ensure compliant stakeholder interactions.
• Work closely with Commercial Operations to develop forecasting, targeting, contracting, and analytics capabilities.
• Recruit, develop, and retain top-tier market access talent.
• Foster a culture of accountability, collaboration, innovation, and patient focus.
• Establish organizational structure and capabilities appropriate for Bicara’s stage of growth.

Vice President, Market Access

Executive Assistant

• Manage the Chief Commercial Officer’s and Chief People Officer’s respective calendars, meetings and schedules, proactively resolving scheduling conflicts as they arise and prioritizing issues to ensure effective time management.
• Partner closely with the Commercial Leadership Team to stay connected to key priorities, track decisions and action items, coordinate follow-through across stakeholders, and help drive execution of critical initiatives.
• Research, coordinate and secure domestic and international travel arrangements while managing receipts for reimbursement.
• Serve as a member of the Administrative team, actively participating in and contributing to team meetings by suggesting agenda topics, leading or engaging in discussion topics, and collaborating with peers for coverage.
• Demonstrate sound decision-making to efficiently manage calendar activities in a manner that maximizes executives’ time, anticipates their needs and allows sufficient time for proper meeting preparation and debrief.
• Assist with new hire onboarding and team expansion that will include Boston based employees, in addition to field/remote employees.
• Act as a trusted advisor with a high degree of tact, diplomacy, judgment, and discretion at all employee levels, while handling sensitive information with confidentiality and the utmost integrity.
• Execute end-to-end logistics for functional onsite and offsite meetings.
• Coordinate the execution, tracking, and electronic filing of confidentiality agreements, ensuring compliance requirements are met for external stakeholders and meeting attendees.
• Assist with special projects, perform required research and maintain records, as required.

Clinical Operations

• 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 support to senior leadership in defining the deliverables on the clinical trial(s) which coincide with the expectations defined in the departmental and company goals.
• Maintain ongoing communication with team members and all stakeholders including senior leadership and external partners or vendors.
• Foster a sense of inclusion and create a shared sense of purpose.

Senior Project Manager, Clinical Operations

• Build and lead the company’s QMS from the ground up
• Design, implement, and continuously improve an integrated QMS to support all GxP activities
• 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 across the organization
• Collaborate with IT, Quality leaders and other internal stakeholders to implement electronic systems to support Bicara’s QMS
• Develop and oversee core QMS processes, including deviations, CAPA, change control, document control, training, risk management, audits, and Quality Management Review (QMR)
• Ensure systems are simple, effective, and aligned with how teams operate
• Lead or support selected QMS activities (e.g., QMR, audits, inspections) in collaboration with Quality leads
• Establish frameworks and tools to support ongoing inspection readiness
• Provide coordination and project management for inspections and related activities
• Define and monitor key quality metrics and trends and collaborate with quality and operational leads to establish governance forums to drive continuous improvement
• Drive adoption and optimization of eQMS tools and the integration and continuous improvement across QMS processes

Senior Director, GxP Quality Management Systems

• 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.
• Co-development and execution of the Medical Affairs Launch Plan with VP Medical affairs, ensuring alignment with commercial, clinical, and regulatory timelines.
• Define pre-launch KOL identification and mapping strategy, ensuring MSLs are engaged with key academic centers, community practices, and emerging thought leaders ahead of approval.
• Oversee strategic KOL engagement across the full spectrum — from academic opinion leaders to community-based key practitioners.
• Collaborate with Medical Affairs leadership to design and execute MSL onboarding and continuous training programs, including therapeutic area expertise, product data, and engagement skills.