Associate Director or Director, Clinical Outsourcing

Description: 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 p…

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