New · posted Oct 31
Bicara Therapeutics · Biotechnology
Senior Clinical Trial Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
Bicara 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.
What you need
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.
What you'll do
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.
Pay
$179,000 – $206,000 a year
Employer provided
From the posting
About Bicara Therapeutics
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.
Equal opportunity, accessibility and legal noticesBicara Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $179,000 | — | $206,000 |
| All US (middle half) | $149,000 | $163,000 | $175,000 |
This role: Bicara Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 70 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Bicara Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct15
- Collaboration and leadership9
- Documentation and SOPs5
- GMP and compliance2
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems2
- Lab testing and methods1
- Regulatory submissions1
Company hiring pulse
Bicara Therapeutics on Regulatory Jobs
- 1
- Open roles
- 1
- Distinct roles
- 1
- Locations
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Senior Clinical Trial Manager at Bicara Therapeutics
Open until filled. $179K–$206K a year, employer provided.