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 or Director, Clinical Outsourcing to serve as BBOT’s dedicated clinical outsourcing lead, owning the end-to-end management of all CRO and vendor relationships across BBOT’s oncology pipeline. Reporting to the VP, Development Operations, this individual will be responsible for all aspects of clinical outsourcing including proposal management, contracting, budget negotiation, vendor governance, and financial tracking—partnering closely with Clinical Operations and other Development functions, Finance, Legal, and program teams to ensure BBOT’s outsourced activities are executed on time, on budget, and to the highest quality standards. Level of appointment will be commensurate with experience.

Responsibilities

Vendor Selection and Outsourcing Strategy 

• Own and continuously refine BBOT’s clinical outsourcing strategy, ensuring a fit-for-purpose vendor model that supports the company’s early-phase oncology pipeline and scales with portfolio growth
• Lead the CRO and vendor selection process for all clinical programs, including preparation of Requests for Proposals (RFPs) and Requests for Information (RFIs), evaluation of vendor capabilities, and coordination of bid defense      meetings
• Establish and maintain preferred provider relationships with pre-negotiated pricing frameworks for core clinical services, reducing cycle times and improving cost predictability across programs
• Partner with Clinical Operations, Clinical Pharmacology, Translational Medicine, and other functions to identify outsourcing needs early, ensuring vendors      are selected and onboarded ahead of program timelines

Contracting and Budget Negotiation 

• Lead negotiation of all CRO and vendor contracts, work orders, change orders, master      service agreements and clinical budgets; drive commercially favorable      terms while maintaining strong vendor relationships and ensuring contract      terms are aligned with BBOT’s operational and regulatory requirements
• Manage the full contract lifecycle for all clinical vendors—from initial scope      development and proposal review through change order management,      amendments, and contract close-out with final financial reconciliation
• Review and critically evaluate vendor proposals and budgets against industry      benchmarks; identify and challenge assumptions, gaps, and areas of risk to      ensure BBOT receives appropriate value and pricing for outsourced services
• Partner with Legal to ensure all vendor agreements are compliant with applicable      regulations, BBOT policies, and GCP requirements; coordinate timely      execution of pharmacovigilance agreements (PVAs), confidentiality      agreements, and quality agreements as required
• Track all contract timelines, expiry dates, and renewal requirements;      proactively initiate renewal or close-out processes to avoid gaps in  vendor coverage

Financial Management and Accruals 

• Own the  monthly and quarterly financial review process for all outsourced clinical      activities; work closely with Finance to ensure accurate accruals,      purchase order management, and budget tracking across all programs
• Partner with Global Study Leads to review and approve vendor invoices, verifying      charges against executed contracts, work orders, and actual deliverables      completed; identify and resolve discrepancies in a timely manner
• Maintain current and accurate budget forecasts for all outsourced activities;      provide regular reporting to program teams, Finance, and senior leadership      on spend status, forecasted variance, and risks
• Support clinical trial budget development at the program level by providing      outsourcing cost estimates, benchmarking data, and vendor-specific inputs      to inform annual budgets and long-range financial plans
• Lead or support close-out financial reconciliation at the end of vendor      engagements, ensuring all contractual obligations are fulfilled and final  payments are accurate and well-documented

Vendor Governance and Performance Oversight 

• Establish and maintain a vendor governance framework for all clinical outsourcing  relationships, including KPIs, performance scorecards, and escalation      pathways; conduct regular performance reviews with key CROs and vendors
• Serve as the primary operational point of contact for CRO and vendor relationship management; proactively identify and resolve performance, quality, or      timeline risks before they impact program delivery
• Ensure  all outsourced activities are conducted in compliance with GCP, applicable regulations, and BBOT SOPs; support audit and inspection readiness for all      vendor-related documentation
• Partner  with Clinical Operations program teams to ensure seamless day-to-day  integration between BBOT and its outsourced partners, driving clear      accountability for deliverables and milestones

Requirements

Education and Qualifications – Associate Director or Director, Clinical Outsourcing 

• Bachelor’s degree in life sciences, business, or a related field; advanced degree      preferred
• Minimum 10  years of experience in clinical outsourcing, vendor management, or      clinical operations in a pharmaceutical or biotechnology setting, with      direct experience in CRO contracting, budget negotiation, and financial      management
• Demonstrated      experience managing the full vendor contract lifecycle, including RFP      development, proposal evaluation, contract negotiation, change order      management, and close-out
• Strong      financial acumen with hands-on experience supporting clinical trial budget      tracking, accruals, and monthly/quarterly finance reviews
• Working      knowledge of ICH-GCP and the regulatory requirements governing clinical      trial outsourcing
• Excellent      negotiation, organizational, and communication skills; ability to manage      multiple vendor relationships and competing priorities simultaneously
• Prior      experience in a lean or startup biotech environment is highly desirable

Education and Qualifications – Director, Clinical Outsourcing 

• Bachelor’s      degree in life sciences, business, or a related field; advanced degree      preferred
• Minimum      10 years of experience in clinical outsourcing, vendor management, or      clinical operations, with a strong track record of independently managing      complex, multi-vendor outsourcing programs across global oncology trials
• Proven      expertise in CRO and vendor contract negotiation, budget development, and      financial oversight at the program and portfolio level, including direct      experience with clinical trial costing, benchmarking, and forecasting
• Experience      establishing preferred provider frameworks and strategic outsourcing      models that improve efficiency and reduce costs across a clinical      portfolio
• Strong      financial acumen with demonstrated ownership of monthly/quarterly accrual      processes, invoice review, and budget variance reporting in close      partnership with Finance
• Deep      working knowledge of ICH-GCP, FDA regulations, and global regulatory      requirements relevant to clinical outsourcing and vendor oversight
• Demonstrated      ability to build and maintain high-performing vendor relationships while      driving accountability for quality, timelines, and cost; experience      leading vendor governance frameworks and KPI reviews
• Oncology      experience preferred; early-phase oncology experience a plus
• Prior experience in a lean, startup, or high-growth biotech environment is highly desirable