Associate Director, TMF Operations Lead

BridgeBio Pharma

3d•$191,000 - $220,000•Hybrid

About The Position

ML Bio Solutions is searching for an experienced TMF Operations Lead to develop and implement the strategy for ensuring completeness and accuracy of the TMF for all BBP-418 clinical trials. This individual will establish and lead the TMF strategy across the BBP-418 clinical development program, ensuring inspection readiness through proactive oversight, quality management, and cross-functional collaboration. This individual will serve as the TMF Subject Matter Expert, driving process improvements, overseeing CRO performance, and fostering a culture of TMF excellence that aligns with ICH-GCP, regulatory expectations, and company standards.

Requirements

University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 8 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered
8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials
Understanding of the drug development life cycle
Experience in handling clinical trial-related documents required
Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
Excellent organizational skills and possess high standards and great attention to detail
Strong communication skills – verbal and written
Highly conscientious and takes initiative to efficiently resolve issues
Must be resourceful and adaptable to support multiple competing demands and changing priorities
Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management
Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint

Responsibilities

Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards.
Establish TMF governance across the clinical development program by monitoring TMF health, quality metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership.
Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans.
Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely document filing, issue resolution, and consistent execution of TMF processes.
Provide strategic oversight of CRO-managed TMF activities through performance metrics, governance meetings, quality reviews, issue escalation, and continuous improvement initiatives.
Lead TMF inspection readiness activities, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up.
Identify TMF compliance risks and quality trends, develop mitigation strategies, and drive corrective and preventive actions to maintain a state of continuous inspection readiness.
Serve as the TMF Subject Matter Expert by providing strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives.
Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program.
Foster a culture of TMF excellence through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF quality and efficiency

Benefits

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
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
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