Associate Director/Director, Clinical Operations

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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. Mavericks WantedWhen 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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You'll DoThe AD/Director, Clinical Operations is responsible for oversight and management of clinical program(s) and functional activities as assigned.

This position will require you to function as a cross-functional study team lead in a fast-paced environment for the clinical development program. This role should demonstrate strong matrix management skills, confidence in working independently and have proven ability to champion a team to deliver on key study milestones.

ResponsibilitiesRepresent Clinical Operations at the Clinical Development Team, cross-functionally and/or Global Program TeamStudy Planning and Management; Establish and coordinate all on-going study management activities, including leading the cross-functional study team to develop an overall study execution plan to deliver on key study deliverablesPartners closely and effectively with other functions and functional heads to drive program forwardDemonstrates ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking, metrics and reporting activitiesAssists and management of CRO/vendor(s) Scopes of Work (SOW), scope changes, budgets, and vendor payments; creating and tracking on all clinical study budgetsDirects risk mitigation, escalation, and resolution activities both internally as well as with sites and vendorsContributes to building the organization Where You'll WorkThis is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You AreBA/BS required in a scientific / medical field, or equivalent work experienceAt least 10+ years of experience in managing global clinical trials at all stages of development within the biopharma industrySignificant experience with cross-functional leadership and clinical teams, including leading data review, database lock and study reporting activitiesSignificant experience with BLA prep; FDA submissions and FDA audit prep and readinessExperience in Quality Assurance, SOP and study plan writing, CAPA preparation and closureStrong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulationsStrong leadership ability and character to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environmentYou have demonstrated curiosity and adaptability in adopting AI-powered tools and technologiesRewarding Those Who Make the Mission PossibleWe 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 programPre-tax commuter benefitsReferral program with $2,500 award for hired referralsHealth & Wellbeing:Comprehensive health care with 100% premiums covered - no cost to you and dependentsMental 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 needPaid parental leave - 4 months for birthing parents & 2 months for non-birthing parentsFlex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our officeSkill 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 mobilityWe provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp CoachingWe celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities  At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.

Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.

BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$1—$2 USDAs a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For USA based roles: Financial & Rewards   Market-leading compensation    401(k) with employer match    Employee Stock Purchase Program (ESPP)   Pre-tax commuter benefits (transit and parking)   Referral bonus for hired candidates   Subsidized lunch and parking on in-office days   Health & Well-Being   100% employer-paid medical, dental, and vision premiums for you and your dependents   Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)   Fertility & family-forming benefits    Expanded mental health support (therapy and coaching resources)   Hybrid work model with flexibility   Flexible, “take-what-you-need” paid time off and company-paid holidays   Comprehensive paid medical and parental leave to care for yourself and your family   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, & BetterUp Coaching  We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities 

BridgeBio Pharma (NASDAQ: BBIO) is a biopharmaceutical company dedicated to advancing a diverse pipeline of medicines that target genetic diseases. Founded in 2015, BridgeBio is committed to developing innovative therapies that address unmet medical needs in various rare and genetic diseases. With a focus on precision medicine and a patient-centered approach, BridgeBio is at the forefront of revolutionizing treatment options for individuals affected by genetic disorders.