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.

Manage study operations, participant recruitment, and data collection for chronic disease research. Ensure regulatory compliance and support research execution, including IRB submissions and manuscript preparation, while utilizing data management tools...

Title: Biostatistician II Location: United States Department: Research Job Description: Description About the Job The Biostatistician II is responsible for providing statistical expertise and managing the activities for the development, clinical and analytical validation, and regulatory approval of FMI’s diagnostic devices including but not limited to companion diagnostic (CDx) devices. The incumbent ensures valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports and regulatory documents with high quality. This role builds and maintains strong collaborations with other departments across the organization to develop statistical methodologies and models, write study protocols, conduct statistical analyses, write study reports, present responses to statistical and study design questions arising from regulatory authorities or external partners (e.g., academic or Biopharma collaborators), represent FMI at meetings with regulatory agencies such as the Food and Drug Administration, contribute to scientific publications, and/or work with internal and external partners for the development, validation, and regulatory approval of FMI’s diagnostic assays in oncology and beyond. Key Responsibilities - Lead and execute the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based diagnostic devices for oncology and beyond, including but not limited to protocol development, statistical analysis plans and reports, and data reporting. - Develop innovative and creative biostatistical and technical solutions to complex problems. - Represent the biostatistics team with guidance from senior team members within broad cross-functional projects. - Collaborate with cross-functional teams on study design, planning, strategy, data preparation, programming, analysis, and presentation of results. - Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions and respond to review questions with guidance from senior team members. - Maintain biostatistics quality standards, biostatistics best practices, and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelines. - Maintain availability to the wider FMI business for biostatistical interpretation, analysis, and solutions. - Other duties as assigned. - Qualifications: Basic Qualifications: - Master’s Degree in Statistics or Biostatistics and 4+ years of working experience; OR PhD in Statistics or Biostatistics with 2+ years of experience. - Strong programming skills in R - Preferred Qualifications: - Ph.D. in Statistics or Biostatistics with 2+ years of experience as a biostatistician in the biopharmaceutical or medical diagnostics industry, academia or government (e.g., FDA, NIH) - Knowledge and experience with one or more of the following: - Clinical Study Design - Clinical Trials - Time-to event data analysis and longitudinal data analysis - Statistical Methods in Diagnostic Medicine - Clinical and analytical validation of medical diagnostic devices and/or companion diagnostics - Categorical data analysis - Missing data analysis - Real-world data (RWD) analysis - Bayesian Methods - Next Generation Sequencing (NGS) and genomics - - Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective cross-functional partnerships - Excellent communication, presentations and writing skills, and ability to explain complex technical details in clear language - Demonstrated ability of independent thinking - Demonstrated ability to meet project deadlines managing multiple projects simultaneously - Demonstrated record of successful independent work and contributions to team projects - High level of detail orientation with a focus on quality - Understanding of HIPPA and importance of privacy of patient data - Commitment to reflect FMI’s values: Integrity, Courage, and Passion - The expected salary range for this position based on the primary location of Remote is $125,000 - $148,000 per year. The salary range is commensurate with Foundation Medicine’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine’s benefits. #LI-Remote

Provide virtual lifestyle counseling to enhance nutrition and dietary quality, set appointments for clinical trial subjects, and collaborate with project managers to ensure timely completion of visits and documentation.