Director, Clinical Oversight

Position Overview:

Bicara Therapeutics’ Director of Clinical Oversight will play a critical role overseeing clinical trial activities, ensuring they adhere to protocol, regulatory standards, and internal processes. You will work closely with internal teams and external partners to monitor and evaluate clinical trial progress, address issues proactively, and implement corrective actions. Bicara is a fast-paced environment that prioritizes fostering strong relationships internally and externally to drive the success of our clinical trials.

Key Responsibilities:

• Oversee the overall performance of clinical trials from initiation to close-out, ensuring adherence to timelines, budgets, and regulatory requirements.
• Provide regular monitoring and reporting of clinical trial activities to senior management, identifying any potential risks or challenges.
• Conduct regular review of clinical trial data, ensuring the highest level of data integrity and compliance.
• Maintain effective communication with internal and external teams, including Contract Research Organizations (CROs), investigators, study sites and vendors, ensuring smooth collaboration and compliance.
• Proactively identify, escalate, and mitigate risks in trial conduct, including recruitment delays, data discrepancies, and protocol deviations.
• Ensure timely and accurate collection of clinical trial data and ensure that data quality is maintained throughout the study.
• Lead and work cross-functionally in the development, implementation and maintenance of study specific oversight plans, tools and templates for Phase I, II, and III clinical trials.
• Evaluate and recommend improvements to clinical trial oversight processes, ensuring more efficient and effective trial execution.
• Keep up with industry trends, regulatory changes, and emerging technologies to improve clinical trial processes.
• Coordinate cross-functionally to resolve issues, identify and mitigate risks, and support proactive decision-making. Build strong, collaborative relationships across departments.
• Work closely with senior leadership to assess clinical trial performance, identify gaps, and create a work environment that fosters team collaboration and operational excellence.
• Develop and deliver training on lessons learned through audits, inspections and oversight visits
• Lead the evaluation and management of study and/or site-specific escalations related to persistent or serious misconduct or other quality issues.
• Participate, as requested, on quality related projects initiated by internal stakeholders
• Liaise with QA in relation to inspection support requests and client audits, as appropriate
• Liaise with QA and cross-functional project teams on the development and finalization of study level audit finding responses.
• Willingness and ability to travel up to 50%.

Qualifications:

• Bachelor’s degree in life-sciences or a related field
• Minimum of 5 years of experience in clinical trial management, clinical operations or clinical oversight with at least 2 years in a managerial role
• Experience in clinical trial monitoring or oversight within a biotech or pharmaceutical environment in Phase I, II and III studies.
• Current ICH GCP training (within the last 3 years)
• Excellent communication skills, both written and verbal, with experience presenting to leadership and external stakeholders.

Company Overview

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b and Phase 2/3 study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at 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.

To apply, please email your resume/CV to careers@bicara.com. In the subject line include your name and the job title.