Bicara Therapeutics

Title: Executive Assistant Location Boston Employment Type Full time Location Type Hybrid Department G&A Compensation - $125K – $149K • Offers Equity • Offers Bonus The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance. Full-time employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual and company performance. To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. *Base salary ranges are periodically reviewed and subject to change. Job Description: Position Overview Bicara Therapeutics is seeking an Executive Assistant who will provide strategic and comprehensive support to our Chief Commercial Officer and Chief People Officer. Reporting to the Chief Commercial Officer, the ideal candidate will have proven experience in a fast-paced growth environment and be adept at managing a wide range of administrative and executive support tasks. They will build relationships with key stakeholders, exercise unparalleled judgment and excel at cross-functional collaboration in addition to working independently. They should be a solutions-oriented team player who is well-organized, detail-oriented, proactive and enjoys the challenges associated with supporting teams in a fast-paced environment. The ideal candidate is self-directed, an excellent communicator and can successfully balance multiple priorities with some level of ambiguity. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - 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. Qualifications - 5+ years of administrative experience providing support to executives; ideally at the "C-Suite" level. Experience in Commercial and/or HR preferred. - Ability to independently perform administrative duties with speed and accuracy. - Exceptional organizational skills, with keen attention to detail and a strong ability to execute. - Demonstrated ability to handle sensitive and confidential information and situations with care and confidence. - Ability to work across various roles and teams in a dynamic, demanding, and fast-paced environment while remaining flexible, proactive, resourceful, and efficient. - Excellent interpersonal and relationship-building skills; outstanding verbal and written communication skills. - Strong work ethic and ability to manage multiple priorities. - Proficient in MS Office. - High level of commitment, availability for after hours (minimal). - Bachelor's degree preferred. Company Overview Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Title: Senior Director, Regulatory Affairs Location: Boston Department: Development Job Description: 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. - 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. Qualifications - Bachelor's degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, or MD) preferred. - 10-12 years of progressive regulatory affairs experience in the biotech or pharmaceutical industry. - Prior oncology/hematology regulatory experience required, with a track record of contributing to oncology development programs across multiple phases. - Demonstrated experience leading global regulatory strategy, including direct engagement with FDA and EMA; experience with additional ICH regions (e.g., PMDA, Health Canada) strongly preferred. - Proven success leading and preparing teams for health authority meetings and delivering major regulatory submissions (IND/CTA and, ideally, NDA/BLA/MAA). - Demonstrated ability to manage within a cross-functional matrix; prior people management experience highly preferred. - Deep working knowledge of global regulatory requirements, ICH guidelines, and oncology-specific frameworks and expedited pathways (e.g., Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug). - Strong leadership, influencing, and project management skills; comfortable operating within a nimble and fast-paced environment typical of a small, clinical-stage biotech. - Exceptional written and verbal communication skills, including experience presenting to and negotiating with health authorities and senior internal stakeholders. - Detail-oriented, highly organized, and able to manage multiple priorities and competing deadlines. Company Overview Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Role Description 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. - 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 support planned activation timelines. Monitor site performance metrics and follow up on any outstanding issues. - Assist in the preparation, submission, and tracking of regulatory documents to ensure compliance with local and international regulations (e.g., FDA, EMA, ICH-GCP). - Collaborate with Data Management teams to track case report form (CRF) completion and query resolution, ensuring accurate and timely data capture and reporting. Support the review and follow-up of data query resolution, data cleaning activities, and site responsiveness in collaboration with CRO and Data Management teams. - Coordinate with external vendors (e.g., CROs, labs, etc.) to ensure timely delivery of services and supplies required for trial conduct. - Assist in tracking trial budgets, manage study trackers and reports to ensure visibility into timelines and deliverables. - Support inspection readiness activities through ongoing review of TMF quality, completeness, and document reconciliation activities. - Participate in monitoring activities and internal audits to ensure adherence to study protocols and regulatory requirements. Report findings and assist in implementing corrective actions as needed. Qualifications - Bachelor’s degree in life sciences, nursing, or a related field - 3+ years of experience in clinical research or related fields, with 1+ year of experience within the biopharmaceutical industry - Experience in oncology and prior support of regional or global clinical trials across multiple countries is preferred - Strong understanding of ICH-GCP, clinical trial regulations, and start-up processes - Excellent organizational and time management skills with the ability to handle multiple priorities - Strong communication skills, both written and verbal, with the ability to work collaboratively in a small, fast-paced biotech environment. - Proficiency in Microsoft Office Suite including strong skills in Excel - Attention to detail and a commitment to maintaining high-quality standards - Ability to work independently and solve problems proactively - Ability to operate effectively in a fast-paced, global biotech environment with evolving priorities and timelines - Previous experience working with contract research organizations (CROs) and external vendors, preferred - Knowledge of clinical trial management systems (CTMS), electronic trial master file (eTMF) and electronic data capture (EDC) system, preferred - Working knowledge of data management, query resolution, and supply chain logistics, preferred Company Description Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com . Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

• 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.

Role Description 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 mentor other MSL team members, and actively contributes to cross-functional Medical Affairs team. - Effectively executes administrative aspects of regional field activities. - Substantively contributes to, and provides medical leadership for internal cross-functional programs/projects. - Provides responses to unsolicited requests for medical information, often in direct collaboration with Medical Information Services personnel. - Completes accurate and timely reports, project plans, and required documentation requests. - Substantively contributes to scientific publication planning, slide-deck development, training initiatives, and the development/implementation of a Medical Strategy Plan. - Leads national level priority projects or cross-functional initiatives on behalf of Medical Affairs. - Leads interactions for specific select priority projects with external collaborators or groups. - Coordinates with MA Training for identifying or delivering advanced training initiatives. Qualifications - Minimum five (5) years in Pharmaceutical Industry Medical Affairs as MSL/Sr. MSL. Candidates with solid tumor experience preferred. - An advanced degree (M.D., Ph.D. or Pharm.D.) is required with prior experience in the biotech/pharmaceutical or healthcare education environment. - Ability to travel up to 65% of the time: As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate's availability for frequent travel is of paramount importance for professional and programmatic success. - Knowledge of treatment guidelines (NCCN, ASCO, ESMO, etc.), clinical research processes, FDA regulations, CMS reimbursement coverage process, and OIG guidelines. - Knowledge or experience in head and neck tumors/solid tumors is a plus. - Must have the ability to network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors. - Must be highly articulate and self-confident during formal and informal presentations; able to convey complex, scientific ideas fluently to any audience. Travel - Approximately 60-70% domestic travel is required. Company Description Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com . Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.