Senior Clinical Trial Manager (Global)

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.

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.
• 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.
• 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.
• Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, 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.

Career Opportunities: Careers at Bicara

Compensation Range: $179K - $211K