• Design and analyze clinical trials, interpreting complex medical data • Lead on biostatistics tasks requiring technical depth, focusing on quality and continuous improvement • Serve as lead biostatistician for simple to complex clinical studies • Develop statistical analysis plans and reporting specifications • Responsible for statistical aspects of CRF design and edit specifications • Perform statistical analyses and interpret results for clinical studies • Review randomization specifications and dummy randomization schemes • Participate in bid defense meetings

• Provides scientific and/or medical expertise for clinical research aspects of the project • Participates in strategic meetings/advisory boards as key clinical research representative • Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.) • Consults with internal/external stakeholders and internal/external key opinion leaders • Provides support to other functional members of the project team • Interacts with investigators and CROs as the medical or scientific representative • Provides medical and scientific interpretation of efficacy and safety data • Participates in the interactions with regulatory authorities (e.g., FDA, EMEA meetings) • Provides input for a project publication plan, liaises with commercial and works on launch activities when required • Creates and reviews abstracts, and manuscripts created by internal or external sources

Role Description - Organisation, Koordination und Monitoring klinischer Studien gemäß ICH- und GCP-Richtlinien sowie interner SOPs - Rekrutierung, Selektion und Training von Prüfärzten und Studienzentren - Durchführung der Studieninitiierung, des Routine-Monitorings (on-site / remote) und des Abschlussbesuchs an deutschlandweiten Prüfzentren einschließlich Zentrumskommunikation und schriftlicher Dokumentation - Identifizierung von Problemen vor Ort und Eskalation an den Studiensponsor - Konzeptionierung und Einreichung der Unterlagen bei Ethikkommissionen und Bundesoberbehörden sowie Unterstützung bei der Korrespondenz - Termin- und Fristenüberwachung - Pflege von Studiendaten in Datenbanken (Access, Excel) - Unterstützung bei Einreichungstätigkeiten / Führen des TMF Qualifications - mind. 1 Jahr Erfahrung als klinischer Monitor - Sehr gute ICH-GCP- und AMG-Kenntnisse - Sehr gute PC-Anwenderkenntnisse (MS-Office) - Gute Englischkenntnisse in Wort und Schrift - Sehr gute Organisationsfähigkeit, Selbständigkeit, Flexibilität, Zuverlässigkeit - ausgeprägter Teamgeist, Kommunikationsfähigkeit und Aufgeschlossenheit - Idealer Weise Kenntnisse im Bereich Monitoring onkologischer Studien Benefits - Wir bieten Ihnen eine abwechslungsreiche und interessante Tätigkeit in einem wachsenden Unternehmen sowie einen sicheren Arbeitsplatz.

Title: Senior Clinical Trial Manager (Global) Location Boston Employment Type Full time Location Type Hybrid Department Development Compensation - $179K – $211K 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. Position Overview Bicara Therapeutics is seeking a Senior Clinical Trial Manager (Global) to oversee multiple regions and help lead the operational execution required to bring our science to patients. In this role, you will own day-to-day management of one or more clinical trials, partnering closely with cross-functional teams, clinical sites, and CRO partners to ensure studies are executed while maintaining the highest standards of quality and compliance. You will be a key driver of vendor oversight, site performance, and risk management – anticipating challenges before they arise and building the internal and external relationships needed to move our trials forward. You will work alongside a tight-knit, mission-driven team that values collaboration, respect, and urgency. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - 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. 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. - May be responsible for managing a team of Clinical Trial Associates including hiring and career and professional development. Qualifications - Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). - Minimum of 5 years’ clinical trial management experience in the pharmaceutical, biotech and/or CRO industry. - Demonstrated ability to manage global clinical trials, navigating regional regulatory requirements, cultural nuances, and varying site capabilities across multiple geographies - Phase 2/Phase 3 study experience strongly preferred - Oncology study experience strongly preferred. - Clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors. - Global clinical trial management in fast paced CRO outsourced environment required. - Experience and ability to manage global or regional teams in a virtual environment. - Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues. - Must be adaptable and enjoy working in a fast-paced environment. - Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables. - Willingness to travel up to 10-20% of the time. 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.