---
title: 'Senior Clinical Trial Manager at Bicara Therapeutics'
canonical: 'https://feeny.ai/job/senior-clinical-trial-manager-bicara-therapeutics-boston-07s96d5xygx4'
type: 'job'
last_seen: '2026-09-13'
---

# Senior Clinical Trial Manager at Bicara Therapeutics

- **Company:** Bicara Therapeutics
- **Location:** Boston, MA
- **Compensation:** $179k–$211k
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-06-18
- **Last confirmed live:** 2026-09-13
- **Apply:** https://jobs.ashbyhq.com/bicara-therapeutics/e37333c0-a2a1-4832-b531-7a2413e930ad/application

**Skills:** Clinical trial management, CRO oversight, Vendor management, Regulatory compliance, Study document development, Budget planning, Site identification and selection, Clinical supply planning, Data monitoring, Case Report Form design, Phase 2 study experience, Phase 3 study experience, Oncology study experience, Global clinical trial management, Fast-paced environment experience

> Oversee global clinical trial operations, managing cross-functional teams, CROs, and vendors to ensure high-quality study execution. Drive vendor oversight, risk management, and compliance while supporting registration studies in a fast-paced biotech environment.

## Job description

Position Overview 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.

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](http://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.

## About Bicara Therapeutics

## Company Overview
- **One-liner**: Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class bifunctional antibodies that combine tumor-targeting with tumor microenvironment modulation, with a lead asset in head and neck squamous cell carcinoma.
- **Entity Type**: Public (NASDAQ: BCAX)
- **Headquarters**: Boston, Massachusetts, USA
- **Founded**: 2020
- **Founders**: Not publicly listed

## Core Business
- **Industry**: Biotechnology – oncology drug development
- **Target Customers**: B2B (pharma partnerships, licensing) and ultimately cancer patients and healthcare providers
- **Mission**: "Dedicated to improving the lives of people living with cancer through the development of innovative targeted therapies… bringing hope and control back into their lives." [bicara.com](https://www.bicara.com/)

## Products & Services
- **[Ficerafusp alfa (BCA101)](https://www.bicara.com/)**: First-in-class, dual-action bifunctional antibody targeting EGFR and containing a TGF-β ligand trap. Currently in Phase 1/1b clinical development for HPV-negative head and neck squamous cell carcinoma and other solid tumors. Mechanism designed to deliver an immunomodulatory payload directly to the tumor microenvironment, reduce fibrosis/immunosuppression, and enable immune cell penetration. (Biologic, clinical-stage therapeutic)

## Market Standing
- **Valuation/Market Cap**: ~$1.3 billion (as of mid-2026) [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics)
- **Key Metric**: Total funding raised $825M (includes Series C $165M led by The Rise Fund and TPG, $362M from 2024 IPO, and a $150M post-IPO equity round in February 2026) [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics)
- **Notable Investors/Partners**: The Rise Fund, TPG, Biocon (seed round). Additional institutional investors from IPO and follow-on offerings.
- **Growth Signals**: IPO completed September 2024; headcount grew 78.1% year-over-year (95 employees, though LinkedIn notes a slight monthly decline of -0.9%); operates across 8 countries including the UK, Italy, Germany, India, and Spain; 11 active job postings as of mid-2026. [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics)

## Competitive Advantages
- **First-in-class bifunctional approach**: By combining an EGFR-targeting antibody with a TGF-β trap, BCA101 directly addresses a key solid-tumor resistance mechanism (TGF-β-driven immunosuppression and fibrosis) while localizing therapy to the tumor.
- **Potential for superior efficacy and safety**: Designed to deliver synergistic therapeutic impact at the tumor site, aiming for deep, durable responses with reduced systemic toxicity.
- **Experienced leadership**: Team with deep oncology drug development backgrounds and relationships with top cancer centers. [bicara.com/about](https://www.bicara.com/about/)

## Strategic Focus
- **Priority**: Advancing ficerafusp alfa through clinical development toward potential regulatory approvals, initially in HPV-negative head and neck squamous cell carcinoma.
- **Pipeline expansion**: Leveraging the bifunctional antibody platform (BCA101 and follow-on programs) to address multiple solid tumor types.
- **Commercial readiness**: Hiring senior roles in medical affairs, quality, regulatory, and commercial operations signals preparation for launch. [bicara.com/careers](https://www.bicara.com/careers/)

## Why Work Here
- **Culture & Mission**: A patient-first, mission-driven environment focused on developing meaningful new therapies for cancer. Company describes itself as "dynamic" with a shared passion for advancing science. [bicara.com](https://www.bicara.com/)
- **Diversity & Inclusion**: Explicitly states commitment to building diverse teams and encourages applicants from all backgrounds. [bicara.com/careers](https://www.bicara.com/careers/)
- **Growth Trajectory**: Fast-growing public company (78% headcount growth YoY) with a strong balance sheet, offering career progression opportunities.
- **Work Environment**: Headquarters in Boston with a global presence. Specific remote/hybrid policy not publicly detailed, but the company employs staff across 8 countries. Glassdoor rating of 4.0/5 on LinkedIn based on limited reviews. [linkedin.com](https://www.linkedin.com/company/bicara-therapeutics)
- **Engagement**: Active hiring across multiple senior-level roles in medical affairs, regulatory, quality, IT, and clinical operations, indicating a ramp-up toward commercialization. [bicara.com/careers](https://www.bicara.com/careers/)

## Sources
1. [bicara.com](https://www.bicara.com/) – Company home page, product, mission
2. [bicara.com/about](https://www.bicara.com/about/) – Leadership team, technology description
3. [bicara.com/careers](https://www.bicara.com/careers/) – Open positions, culture, diversity statement
4. [linkedin.com/company/bicara-therapeutics](https://www.linkedin.com/company/bicara-therapeutics) – Headcount, financials, stock info, employee reviews, talent sources
5. [massbio.org/members/bicara-therapeutics](https://www.massbio.org/members/bicara-therapeutics/) – Membership description, pipeline summary

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