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 a Vice President, Development Operations to serve as a key operational and strategic leader within BBOT’s Development organization. Reporting to the CMO/CDO, the VP will have functional ownership of Clinical Operations and Outsourcing, the oversight of contractors and consultants across the Development organization, and oversight of other functions/resources as assigned. This Leader will build and enforce a culture of operational excellence, compliance, and continuous improvement—ensuring that BBOT’s development operations infrastructure scales effectively as its oncology pipeline advances. The ideal candidate brings deep Clinical Development and Clinical Operations expertise in the oncology space, proven people leadership capabilities, and a track record of building best-in-class teams at a lean, high-growth biotech.

Responsibilities

Strategic Leadership and Organizational Development 

• Serve as a key member of the      Development leadership team, reporting to the CMO/CDO and contributing to portfolio-level      strategy for BBOT's clinical pipeline
• Define and execute the      operational strategy for the Development organization, ensuring that      systems, processes, and infrastructure are fit-for-purpose and scalable      for future growth; collaborate with IT to develop and maintain tools,      licenses, and environments needed by Development functions
• Establish and foster a culture      of operational excellence, efficiency, accountability, and continuous      improvement across all functions under the VP’s remit
• Proactively identify      organizational gaps and design practical, cost-effective solutions that      align with BBOT’s lean operating model and stage of development
• Represent Development      Operations in engagements with senior leadership, the Board of Directors,      and external partners, as appropriate

Clinical Operations and Outsourcing Oversight 

• Provide strategic and      operational oversight of BBOT’s clinical programs, ensuring high-quality      execution across all studies on time, within budget, and in compliance      with GCP/ICH guidelines and applicable regulatory requirements
• Lead BBOT’s clinical      outsourcing strategy, overseeing the selection, contracting, onboarding,      and performance management of CROs, central labs, and other clinical      vendors; develop and maintain a vendor governance framework that ensures      transparency, accountability, and fiscal responsibility across all      external partnerships
• Partner with program managers      and program leads to drive cross-functional alignment on trial timelines,      site performance, enrollment strategy, and risk mitigation; provide      operational input into protocol development, study design, and resource      planning
• Oversee budget tracking,      forecasting, and vendor invoice review for outsourced activities in      partnership with Finance; identify emerging outsourcing models to optimize      BBOT’s approach to clinical execution as the portfolio expands
• Oversee inspection readiness      and quality across all active clinical programs, ensuring eTMF      completeness and audit-ready standards are maintained at all times

Contractor and Consultant Oversight

• Provide day to day oversight of      the engagement, onboarding, timesheet tracking, invoice payment, and      offboarding of contractors and consultants across the Development      organization, with input from functional SME’s overseeing contractor and      consultant work as needed
• Partner with Finance, Legal,      and HR to ensure contractor engagements are compliant, cost-effective, and      appropriately scoped and budgeted
• Maintain visibility into      consultant utilization and performance across Development functions,      identifying gaps and optimizing the use of external expertise

SOPs, Compliance, and Process Excellence 

• Accountable for development,      maintenance, training, and compliance of SOPs across Development      functions, in partnership with functional leads and SME’s
• Partner with Quality and      Regulatory Affairs to ensure all Development Operations activities are      conducted in accordance with ICH-GCP guidelines, FDA regulations, and      applicable global regulatory requirements
• Lead or oversee preparation for      regulatory inspections and internal audits; serve as the senior      Development Operations contact during inspections
• Implement KPIs/metrics,      dashboards, and governance structures to monitor operational performance,      compliance, and efficiency across Development functions
• Champion change management      initiatives that improve operational processes and drive adoption of best      practices across the Development organization

People Leadership and Mentorship 

• Build, lead, and develop a      high-performing Development Operations team; oversee activities related to      hiring and retention among assigned functions
• Provide ongoing coaching,      mentorship, and performance management to direct reports and broader      functional teams, fostering a culture of growth, accountability, and      collaboration
• Establish clear goals,      development plans, and career pathways for team members at all levels
• Serve as a role model for      BBOT’s values, promoting a high-performance, inclusive, and mission-driven      culture across the Development organization

Requirements

Education and Qualifications 

• Bachelor’s degree in life      sciences, business, or a related field required; advanced degree (M.S.,      M.B.A., or Ph.D.) preferred
• Minimum 15 years of progressive      experience in clinical development operations within the biopharmaceutical      industry, with at least 5 years in a senior leadership role overseeing one      or more Development functions
• Proven experience managing and      developing high-performing teams, including direct leadership of      functional managers and senior individual contributors
• Deep expertise in clinical      operations, clinical outsourcing, and CRO/vendor governance across global      early- and late-phase oncology trials
• Proven track record of      developing, implementing, and maintaining SOPs and quality systems in a      GCP-regulated environment
• Strong understanding of ICH-GCP      guidelines, FDA regulations, and global regulatory requirements governing      the conduct of clinical trials
• Exceptional organizational,      analytical, and interpersonal skills; demonstrated ability to influence      and drive alignment across functions and levels
• Strong financial acumen,      including experience with clinical trial budget management, vendor      contracting, and forecasting
• Oncology experience required;      early-phase and late-phase oncology experience strongly preferred
• Prior experience in a lean,      startup, or high-growth biotech environment is highly desirable; ability      to operate effectively with limited resources and high ambiguity
• Excellent written and verbal      communication skills, with the ability to present complex operational      topics clearly to the CMO/CDO, Board of Directors, and external partners
• Proficient in clinical trial      systems (e.g., CTMS, eTMF, EDC) and timeline management tools (e.g.,      Smartsheet)