Manager/Senior Manager, Clinical Outsourcing Remote - United States

Company: BridgeBio Pharma
Location: Palo Alto
Posted on: February 3, 2025

Job Description:

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.Our focus on scientific excellence and rapid execution aim to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.The Manager/Sr. Manager of Clinical Outsourcing leads vendor outsourcing, negotiation, contracting, and supports vendor relationship management for assigned vendor categories and functions across specified BridgeBio affiliates within BridgeBio's clinical development portfolio. This role will demonstrate a strong understanding of outsourcing models and strategies, contracting business terms, 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 contracts across BridgeBio programs and affiliates. S/he will be responsible for leading the request for information/proposal (RFI/RFP) process and vendor selection; analyzing bids, negotiating clinical development service provider contract business terms, reviewing and negotiating change orders and budgets; managing financial and contract approvals while consistently fostering an environment of collaboration and transparency between internal stakeholders and external business partners.Responsibilities

• Work closely across assigned BridgeBio affiliates and functions to implement and manage vendor outsourcing strategies and costs
• Respond to internal requests for service provider needs for assigned functions and programs
• Manage the RFI and RFP/vendor selection process including preparing RFPs, reviewing proposal responses and conducting budget analysis and comparisons and negotiations
• Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across assigned programs and vendors
• Lead and manage 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 and programs are within budget
• Support contracting for various service providers including CROs, ancillary clinical providers such as laboratories, IRT, and other specialty vendors, Clinical Pharmacology providers, and Pharmacovigilance and Biometrics vendors
• 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 vendor relationships and performance indicators across affiliates
• Prepare justification and lead financial approvals and signatures process for assigned functional vendors and programs
• Support the affiliate functional teams in managing service provider relationships and escalations
• Facilitate or participate in vendor governance and business review meetings
• Support Clinical Outsourcing function strategic initiatives and infrastructure including process optimization, tracking, reporting, and template and tool improvementsNo matter your role at BridgeBio, successful team members are:
  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills Requirements
    • BS or BA or equivalent degree
    • 5 years in biotech/pharma/clinical research industry with 3 years of clinical operations or clinical development outsourcing experience or equivalent
    • Solid understanding of outsourcing and contracting best practices for all phases of clinical research with knowledge of the drug development process and cross-functional clinical team responsibilities including clinical trial design, study start-up and execution, monitoring and site management, PV database and safety reporting, regulatory affairs, and data management, and biometrics
    • Experience soliciting, reviewing, and analyzing service provider proposals and budgets, and managing vendor relationshipsCore Competencies
      • Strong attention to detail, analytical, negotiating and business communication skills
      • Ability to interact and influence effectively with multi-functional teams at all levels of internal and external organization
      • 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-directedWhat We Offer
        • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
        • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
        • A place where you own the vision - both for your program and your own career path
        • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
        • Access to learning and development resources to help you get in the best professional shape of your life
        • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
        • Flexible PTO
        • Rapid career advancement for strong performers
        • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
        • Commitment to Diversity, Equity & Inclusion
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Keywords: BridgeBio Pharma, Santa Rosa , Manager/Senior Manager, Clinical Outsourcing Remote - United States, Executive , Palo Alto, California