Associate Director, Clinical Project Management — BLA Readiness

Bicara Therapeutics; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Bicara Therapeutics is seeking an Associate Director, Project Management (Clinical Operations) to lead cross-functional program plans, coordinate BLA submission activities, and mitigate risks for late-stage oncology trials. The role emphasizes strong communication, organization, and strategic execution within a fast-paced environment.

Reporting to the Senior Director, Clinical Operations, you will drive milestone tracking, budget oversight, vendor coordination, and audit readiness while

Qualifications

• Bachelor’s degree in life sciences or a related field.
• 7+ years of industry experience, including 4+ years of clinical project management experience within biotechnology or pharmaceutical industry.
• Strong preference for experience supporting late-stage clinical development programs, 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.
• Willingness to travel up to 10–15% of the time.

Responsibilities

• Serve as the Clinical Operations point of contact for BLA submission activities and subsequent Health Authority submissions, coordinating cross-functional deliverables and timelines.
• Drive efficient execution for the Phase III FORTIFI trial through integrated project planning, milestone tracking, budget oversight, and management of invoices and accruals.
• Partner with leadership to drive cross-functional visibility into trial progress and ensure timely deliverables.
• Support internal and external meetings with agendas, minutes, presentations, and decisions.
• Oversee management and coordination of ancillary clinical trial supplies.
• Maintain clinical study plans and manuals with version control and training.
• Identify, assess, and mitigate clinical trial risks and support audit readiness.
• Define and prioritize deliverables aligned with objectives.
• Support IP forecasting and tracking with Clinical Supply and Leadership.
• Lead risk management review and protocol deviation review processes.
• Establish and maintain clear communication across teams, senior leadership, CROs, vendors and stakeholders.
• Foster an inclusive, collaborative environment and shared accountability across the team.

Skills

Clinical project management

Cross-functional coordination

Risk management

Leadership

Communication

Attention to detail

Strategic planning

Problem solving

Stakeholder management

Adaptability

Education

Bachelor’s degree in life sciences or a related field

Job description

Bicara Therapeutics is seeking an Associate Director, Project Management (Clinical Operations) to lead cross-functional program plans, coordinate BLA submission activities, and mitigate risks for late-stage oncology trials. The role emphasizes strong communication, organization, and strategic execution within a fast-paced environment.

Reporting to the Senior Director, Clinical Operations, you will drive milestone tracking, budget oversight, vendor coordination, and audit readiness while