{"id":1013952,"url":"https://alion.io/job/bicara-therapeutics-senior-clinical-trial-manager","title":"Senior Clinical Trial Manager","company":{"id":669311,"name":"Bicara Therapeutics","domain":"bicara.com","url":"https://alion.io/company/bicara","size_band":"51-200","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Ashby","truth_index":null},"role":"Finance","role_family":"Finance","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":179000,"max":206000,"currency":"USD","period":"year","gross":null,"usd_annual":206000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-17T20:26:00Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-09-24T08:15:57Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Position Overview\nBicara Therapeutics is seeking a Senior Clinical Trial Manager 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.\nResponsibilities\nExecute Bicara’s clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.\n\nSupport 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.\n\nWork closely with external collaboration partners with a focus on relationship management and efficiency\n\nLead the proactive identification, assessment, and management of clinical study challenges and risks.\n\nSupport the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.\n\nMonitor 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.\n\nWork with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.\n\nParticipate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.\n\nParticipate 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.\n\nOversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.\n\nExecute 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.\n\nContribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.\n\nMay be responsible for managing a team of Clinical Trial Associates including hiring and career and professional development.\n\nQualifications\nBachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).\n\nMinimum of 5 years’ clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.\n\nDemonstrated ability to manage global clinical trials, navigating regional regulatory requirements, cultural nuances, and varying site capabilities across multiple geographies\n\nPhase 2/Phase 3 study experience strongly preferred\n\nOncology study experience strongly preferred.\n\nClinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.\n\nGlobal clinical trial management in fast paced CRO outsourced environment required.\n\nExperience and ability to manage global or regional teams in a virtual environment.\n\nStrong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.\n\nMust be adaptable and enjoy working in a fast-paced environment.\n\nEffective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.\n\nCompany Overview\nBicara 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.\nHere 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.\nBicara 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.","description_format":"text","description_chars":5820,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Research","Biotechnology","Health Care","Pharmaceuticals"],"lifecycle":[{"event":"open","at":"2026-09-17T21:38:08Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":6,"expected_fill_days":32,"reasons":["conf:0","win:early"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":206000,"is_top_pay":true},"html_url":"https://alion.io/job/bicara-therapeutics-senior-clinical-trial-manager","json_url":"https://alion.io/job/bicara-therapeutics-senior-clinical-trial-manager.json","meta":{"generated_at":"2026-09-24T09:39:00Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}