Senior Manager, Clinical Outsourcing

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BridgeBio ultimately exists to help patients. Millions worldwide are afflicted with genetic diseases, but small patient populations and industry reluctance to conduct early-stage development means that for many, treatments have not been forthcoming. We are committed to bridging this gap: between the business case and scientific possibility, between patient and hope.

To learn more, visit us at https://bridgebio.com

Location

San Francisco, CA

Who You Are

The Senior Manager of Clinical Outsourcing leads vendor outsourcing, negotiation, contracting and supports vendor relationship management across BridgeBio’s clinical development portfolio. This role will demonstrate an in-depth knowledge of outsourcing models and strategies, contracting, financials, and cost-effective best practices, a thorough understanding of clinical operations, clinical trial services and 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 and its affiliates as well as provide support for Outsourcing infrastructure and process development. This individual 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 the Clinical Development and Early Development Leadership across BridgeBio affiliates to define, implement, and manage vendor strategies and costs
  • Respond to internal requests for CRO and clinical and early development service provider needs
  • Independently lead and be accountable for the RFI and RFP/vendor selection process including preparing RFPs, and reviewing proposal responses and conducting complex budget analysis and comparisons
  • Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio
  • Lead and manage the large, complex contract and financial negotiations with external service providers (including detailed scopes of work, exhibits, payment terms, budgets, change orders) to ensure competitive market prices are obtained, 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 of parent and subsidiary CRO and service provider relationship histories and agreement obligations
  • Support the clinical and early development 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) 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
  • Support the BridgeBio parent company strategic outsourcing initiatives including preferred provider relationships and negotiations
  • Provide input and actively participate in optimizing key business processes

Education, Experience & Skills Requirements

  • BS or BA
  • 8 years of experience in the biotech/pharma/clinical research industry; at least 5 years of experience in 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
  • Experience with early development/preclinical vendors and contracting is preferred

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
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Senior Manager, Clinical Outsourcing

Apply Now