Director, Clinical Outsourcing
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
The Director of Clinical Outsourcing will lead vendor outsourcing, negotiation, contracting, and vendor relationship management across affiliates and programs within BridgeBio’s clinical development portfolio. This role demonstrates 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 take ownership of initiatives and improvements within the Outsourcing function 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
- Partner with Clinical Operations, Clinical Development and R&D Leadership across BridgeBio affiliates to define, implement, and manage vendor strategies and costs
- Partner with internal BridgeBio Services functions, including FP&A, Accounting, and Legal to ensure compliance with business processes and policies
- Lead responses 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 and 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, change orders) to ensure competitive market prices and savings objectives are met
- Manage direct reports (if applicable), including recruitment, onboarding, career development coaching and/or may provide oversight and mentorship and coaching to more junior team members
- Independently 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
- Lead/manage key CRO or other vendor relationships centrally, including ownership of business terms, preferred provider terms, central communications, central meetings, and escalations and governance
- 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
- Lead BridgeBio parent company strategic outsourcing initiatives, including preferred provider relationships and ownership of internal cross functional relationships
- Lead creation or optimization of outsourcing business processes, including documentation of process workflow, creation of templates, tools, tracking and vendor outsourcing best practices
Where You'll Work
This is a hybrid role and requires in-office collaboration in our San Francisco Office on a monthly basis.
Who You Are
- BS or BA or equivalent degree
- 10 – 15 years in biotech/pharma/clinical research industry in clinical operations or outsourcing role
- 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
Core 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-directed
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
- Market-leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing:
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Salary
$215,000 - $248,000 USD
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