Note: The job is a remote job and is open to candidates in USA. Bicara Therapeutics is a clinical-stage biotechnology company developing targeted tumor-modulation therapies. The Associate Director will lead clinical operations project management, coordinate BLA and Health Authority submissions, drive execution of a Phase III trial, and manage cross-functional plans, risks, deliverables, and stakeholder communications.
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
Skills
- 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 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
- Strong preference for experience supporting late-stage clinical development programs, particularly oncology trials, with exposure to BLA and/or NDA submission activities
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