Head of Clinical Outsourcing (Director/Sr. Director)
SVP, Development Operations
The Head of Clinical Outsourcing is a leadership role with the remit to develop and demonstrate in-depth knowledge of clinical outsourcing models and strategies, contracting and cost-effective best practices, clinical trial services and technologies, cost drivers and assumptions associated with clinical research and management of key vendor relationships.
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 subsidiaries. S/he will be responsible for conducting service needs analyses; leading the preparation, distribution, and analyses of responses to requests for information/proposal (RFI/RFP); leading and documenting CRO and other clinical service providers evaluation and selection activities; negotiating CRO/service provider contracts and budgets; measuring and reporting CRO/service provider performance; and fostering an environment of collaboration and transparency between internal stakeholders and external business partners.
Job Responsibilities & Functions:
- Work closely with clinical study teams and Development Operations (DevOps) leadership to define, implement, and manage outsourcing strategies and activities.
- Establish standardized clinical outsourcing best practices, procedures and tools at the parent company level.
- Respond to DevOps requests for CRO and clinical services.
- Lead and be accountable for the RFI and RFP process.
- Maintain appropriate documentation related to CRO and service provider selection, oversight, and performance.
- Continually identify opportunities to reduce costs, increase efficiency, optimize service provider relationships and value, mitigate risk, including shifts in industry trends and technologies as well as service provider mergers and acquisitions.
- Demonstrate creativity and foresight in anticipating and solving complex service provider relationship and performance issues.
- Lead and manage contract and pricing negotiations to ensure competitive market prices are obtained, savings objectives are met, and the best interests of BridgeBio and its entities are safeguarded.
- Capture and report negotiated and value-add savings.
- Communicate directly with senior management regarding progress and financial status of outsourced projects and potential risks.
- Work with Finance and DevOps to track accruals and forecasts related to CRO and service provider spend. Highlight to senior management potential financial risks and fluctuations.
- Promote effective communications and transparency and act as central point of contact for CRO/service provider interactions. Act as a point of contact for issue escalation.
- Maintain knowledge base of parent and subsidiary CRO and service provider relationship histories and agreement obligations.
- Benchmark within our industry to establish and update best practices for outsourcing, contracting and cost efficiencies.
- Provide vision, leadership, motivation for and performance management of direct reports as assigned.
- Support the clinical teams in managing service provider performance and risk.
- Develop, implement and manage appropriate CRO governance structures.
- Develop and refine CRO and service provider key performance indicators (KPIs) that will 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, oversight plans.
- Some travel required (10%).
Preferred Education and Experience:
- BS or BA, MS, Ph.D, or PharmD.
- 10 years in biotech/pharma clinical research industry; 5 years clinical outsourcing and management experience.
- Expert in outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities including: clinical trial design, study start-up and execution, CRA 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 strategic relationships.
- Proven track record for delivering strategic initiatives within timeline and budget constraints and for implementing and executing CRO and service provider oversight, performance, and relationship management processes.
- Strong interpersonal, communication and presentation skills to be able to engage with all levels both within BridgeBio and entities and with our CRO and clinical service providers.
- Forward-thinking and creative with high ethical standards.
- Ability to work in a fast-paced environment with drug development professionals.
- Strong problem-solving skills.
- Ability to lead and manage cross-functional initiatives from concept to completion.
- Ability to distinguish proper balance between strategic and tactical thinking and react to DevOps and clinical study team needs.