Associate Director or Director, Clinical Outsourcing

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