About BridgeBio Oncology Therapeutics

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

We are seeking an Associate Director, Clinical Operations to lead execution of BBOT’s clinical trials across all phases, with a focus on early-phase oncology. Reporting to the Director of Clinical Operations, the Associate Director will serve as the operational lead for assigned studies, driving day-to-day trial management while providing guidance to Clinical Trial Managers and supporting the Director on cross-functional and portfolio-level priorities. The Associate Director will work closely with CROs, vendors, investigators, and internal stakeholders to ensure high-quality, timely clinical data delivery. Global trial experience is required.

Responsibilities

• Lead day-to-day clinical trial      execution for assigned studies, with full ownership of site activation,      enrollment, monitoring, and closeout activities
• Serve as the primary clinical      operations lead for assigned programs, acting as the main point of contact      for CROs, vendors, and clinical sites
• Lead cross-functional trial      team meetings, driving alignment on deliverables, timelines, and risk      mitigation strategies, and escalating portfolio-level issues to the      Director as appropriate
• Provide day-to-day direction      and mentorship to Clinical Trial Managers, supporting their development      and ensuring consistent quality of study execution across the team
• Manage CRO and vendor      relationships for assigned studies, overseeing deliverables, performance      metrics, and issue resolution in partnership with the Director
• Drive vendor integration      strategies to ensure seamless execution between CRO, central labs, and      specialty service providers
• Own study budget tracking and      forecasting for assigned programs, providing regular reporting and      flagging variances to the Director
• Review vendor invoices against      scope of work and work completed to date; identify and communicate      variances to the Director
• Ensure completeness and      inspection-readiness of the trial master file (TMF/eTMF) across assigned      studies
• Lead the development and      maintenance of key operational documents including study manuals, ICFs,      tracking tools, and monitoring plans
• Monitor regulatory and GCP      compliance across all trial activities for assigned studies; lead audit      and inspection readiness preparation and support the Director during      inspections
• Review clinical trial data      listings to identify and drive resolution of protocol deviations, data      trends, and outstanding queries
• Coordinate timely data review      to identify trends and discrepancies; support the Director in contributing      to abstracts, presentations, and manuscripts as needed
• Oversee lab sample management      processes, including sample tracking, shipment, reconciliation, and vendor      coordination to ensure timely and compliant handling of biological      specimens
• Coordinate and plan for      availability of clinical and non-clinical supplies required for trial      execution
• Lead SOP development and      implementation for assigned areas; contribute to continuous process      improvement initiatives across clinical operations
• Cultivate and maintain strong      working relationships with investigators and trial site managers to      support site performance
• Represent clinical operations      in cross-functional team meetings and contribute to governance      discussions, with escalation to the Director for portfolio-level decisions
• Contribute to operational      feasibility assessments and support protocol development in collaboration      with cross-functional teams and the Director

Requirements

Education and Qualifications 

• Bachelor’s degree in life      sciences or related field
• Minimum 8–10 years of      experience in Clinical Operations, managing clinical trials within the      biopharma industry, including global trial experience
• Demonstrated ability to      independently lead clinical trials from start-up through close-out,      including financial tracking, reporting, and vendor management
• Experience providing direction      or informal management to CTMs or equivalent clinical operations staff;      formal people management experience a plus
• Strong understanding of      CRO/vendor oversight and clinical development processes, with a proven      track record managing complex, multi-vendor programs
• Experience with      cross-functional leadership and clinical teams, including data review and      study reporting activities
• Early-phase oncology experience      preferred
• Prior experience in a lean or      startup environment is highly desirable
• Experience in maintenance of a      submission-ready eTMF required
• Experience in Quality      Assurance, SOP and study plan writing, and audit/inspection readiness
• Strong knowledge of ICH-GCP and      global regulatory requirements
• Proficient in clinical trial      systems (e.g., EDC, CTMS, eTMF), timeline management tools (e.g.,      Smartsheet), and Microsoft Office Suite
• Excellent project management,      communication, and problem-solving skills; demonstrated ability to lead      and influence in a cross-functional environment