Associate Director, Project Management (Clinical Operations)

Position Overview

Bicara Therapeutics is seeking an Associate Director, Project Management (Clinical Operations) to provide project management expertise and strong operational support and leadership to the team. The role is highly cross-functional with key interactions with internal and external stakeholders. In partnership with the Senior Director, Clinical Operations, the Associate Director will support the development and the execution of integrated project plans, translating strategic priorities into actionable plans, timelines and milestones. This role will serve as the cross-functional driver for BLA submission coordination, ensuring alignment across functions, timelines, deliverables, and critical dependencies to support a successful submission. The Associate Director will proactively identify critical path activities, dependencies, and project risks, and will drive mitigation strategies to ensure successful delivery.

The successful candidate will have strong communication skills. They will be highly organized, detail oriented, comfortable with ambiguity, have a proven track record of managing and driving projects, and demonstrate cultural alignment with Bicara’s Values of Powered by People for Patients, Adaptive Momentum, and Candor that Elevates. The role will report to the Senior Director, Clinical Operations.

Responsibilities

• Serve as the Clinical Operations point of contact for BLA submission activities as well as subsequent Health Authority submissions in various regions, coordinating cross-functional deliverables, timelines, and readiness across the clinical team and partnering closely with Regulatory and other functional stakeholders.

• Serve as an integral member of the Clinical Operations core team, driving efficient execution for our phase III FORTIFI trial through integrated project planning, milestone and metric tracking, budget oversight and reconciliation, and management of invoices and accruals.

• Partner with Senior Director, Clinical Operations to drive cross-functional visibility into clinical trial progress, ensuring timely execution of internal, CRO, and external partner deliverables.

• Support the planning and execution of internal and external meetings, including agendas, minutes, presentations, and clear documentation of decisions and action items.

• Oversee management and coordination of ancillary clinical trial supplies.

• Lead the maintenance of clinical study plans and manuals, including version control, implementation, and team training, partnering with Bicara cross-functional teams and Quality to ensure most current plans are provided to maintain current training records.

• Partner with cross-functional teams to identify, assess, and mitigate clinical trial risks and support internal and external audit readiness and follow-up.

• Partner with Clinical Operations leadership and cross-functional teams to define and prioritize clinical trial deliverables aligned with departmental and company objectives.

• Support IP forecasting and tracking in collaboration with Clinical Supply and Clinical Operations leadership

• Partner with cross-functional teams on risk management review and protocol deviation review ensuring collaboration and completion according to established plans and procedures.

• Establish and maintain effective communication across cross-functional teams, senior leadership, CROs, vendors, and other external stakeholders.

• Foster an inclusive, collaborative environment and create shared accountability and purpose across the clinical team.

Qualifications

• Bachelor’s degree in life sciences or a related field required.

• 7+ years of industry experience, including 4+ years of clinical project management experience within the biotechnology or pharmaceutical industry.

• Strong preference for experience supporting late-stage clinical development programs, particularly oncology trials, with exposure to BLA and/or NDA submission activities.

• Strong knowledge of ICH/GCP and applicable regulations and guidelines.

• Demonstrated expertise in clinical project management, including planning, execution, milestone tracking, cross-functional coordination, and risk management.

• Strong organizational, leadership, and influencing skills, with the ability to drive progress and build alignment across all levels of an organization.

• Strong analytical, problem-solving, and critical-thinking skills, with the ability to balance attention to detail with a broader strategic perspective.

• Excellent written and verbal communication skills, including the ability to effectively present, facilitate, and communicate complex updates and issues to senior leadership and cross-functional stakeholders.

• Demonstrated ability to operate independently in a fast-paced, results-driven, highly accountable environment; effectively prioritize competing demands, manage multiple workstreams, and integrate cross-functional issues.

• Willingness to travel up to 10–15% of the time.

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.