Sr. Manager/AD, Clinical Outsourcing

About BridgeBio Oncology Therapeutics

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. Initially formed as a subsidiary of BridgeBio Services, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. 

For more information visit bridgebiooncology.com.

Job Description

The Sr. Manager of Clinical Outsourcing leads vendor outsourcing, negotiation, and contracting and supports vendor relationship management across specified BridgeBio Oncology affiliates and programs within BridgeBio Oncology's clinical development portfolio.  This role will demonstrate an in-depth knowledge of outsourcing models and strategies, contracting, financials, and cost-effective best practices, as well as a thorough understanding of clinical operations, clinical trial services, technologies, and the cost drivers and assumptions associated with clinical research. 

This position will work closely with internal and external stakeholders to ensure the successful, cost-effective, and timely execution of clinical research programs sponsored by BridgeBio Oncology and its affiliates and provide support for Outsourcing infrastructure and process development.  S/he will be responsible for leading the request for information/proposal (RFI/RFP) process through vendor selection; analyzing bids, negotiating complex CRO/service provider contracts, reviewing and negotiating detailed change orders and budgets; measuring and reporting CRO/service provider performance; and fostering an environment of collaboration and transparency between internal stakeholders and external business partners.

Responsibilities

• Work closely with Clinical Development and R&D Leadership across assigned BridgeBio Oncology affiliates to define, implement, and manage vendor strategies and costs.
• Respond to internal requests for CRO and clinical service provider needs.
• Independently lead and be accountable for the RFI and RFP/vendor selection process, including preparing RFPs, reviewing proposal responses, and conducting complex budget analysis comparisons and negotiations.
• Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio.
• Lead and manage large, complex contract and financial negotiations with external service providers (including detailed scopes of work, exhibits, payment terms, budgets, and change orders) to ensure competitive market prices are obtained, and savings objectives are met, and the best interests of BridgeBio and its; affiliates are safeguarded.
• Manage review and negotiation of contract business terms and MSAs and partner with internal stakeholders and Legal/Finance as needed to finalize terms and obtain approvals.
• Support tracking parent and affiliate CRO and service provider relationship histories and agreement obligations.
• Support the clinical affiliate teams in managing service provider relationships, performance, and risk.
• Lead or participate in CRO and vendor governance and business review meetings.
• Track CRO and service provider key performance indicators (KPIs) to provide meaningful insights into future CRO and service provider selection decisions.
• Review and provide subject matter expert input into service provider documents, i.e., MSAs, SOWs, quality agreements, and oversight plans.
• Support BridgeBio parent company strategic outsourcing initiatives, including preferred provider relationships and negotiations.
• Provide input and actively participate in optimizing key business processes, templates, tools, tracking, and vendor outsourcing best practices across subsidiaries.

Qualifications

• BS or BA
• Six years in the biotech/pharma/clinical research industry; at least three years of clinical operations or outsourcing experience.
• Expert in outsourcing and contracting best practices for all phases of clinical research with an in-depth understanding of the drug development process and the cross-functional responsibilities, including clinical trial design, study start-up and execution, monitoring, and site management, safety reporting, data management, and biometrics.
• In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor relationships.
• Strong attention to detail, analytical, negotiating, and business communication skills.
• Ability to interact and influence effectively with multi-functional teams at all internal and external organization levels.
• Forward-thinking and creative with high ethical standards.
• Ability to work in a fast-paced professional environment with changing priorities and business needs.
• Strong problem-solving and multi-tasking skills.
• Ability to lead and manage cross-functional initiatives from concept to completion.
• Well-organized and self-directed.