Associate Director/Director, Clinical Operations at BridgeBio Pharma

, , United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

2.0

Posted On

19 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Program Management, Cross-functional Leadership, Study Execution Planning, Matrix Management, Clinical Trial Delivery, Start-up to Close-out Management, Financial Tracking, Metrics and Reporting, CRO/Vendor Management, Budget Management, Risk Mitigation, BLA Preparation, FDA Submissions, FDA Audit Preparation, Quality Assurance, GCP Compliance

Industry

Biotechnology Research

Description

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 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. What You'll Do The 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. Responsibilities Represent Clinical Operations at the Clinical Development Team, cross-functionally and/or Global Program Team Study 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 deliverables Partners closely and effectively with other functions and functional heads to drive program forward Demonstrates ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking, metrics and reporting activities Assists and management of CRO/vendor(s) Scopes of Work (SOW), scope changes, budgets, and vendor payments; creating and tracking on all clinical study budgets Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors Contributes to building the organization Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are BA/BS required in a scientific / medical field, or equivalent work experience At least 10+ years of experience in managing global clinical trials at all stages of development within the biopharma industry Significant experience with cross-functional leadership and clinical teams, including leading data review, database lock and study reporting activities Significant experience with BLA prep; FDA submissions and FDA audit prep and readiness Experience in Quality Assurance, SOP and study plan writing, CAPA preparation and closure Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations Strong leadership ability and character to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies 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 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 USD As 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

Responsibilities

The Associate Director/Director, Clinical Operations will oversee and manage assigned clinical program(s) and functional activities, acting as a cross-functional study team lead in a fast-paced development environment. Responsibilities include establishing study execution plans, partnering with functional heads, managing trials from start-up to close-out, and directing risk mitigation activities.