Associate Director, TMF Operations Lead

BridgeBio
United States
Workplace: RemoteFull timeUSD 191,000 - 220,000 annuallyFunction: Business OperationsExperience: 8+ yearsSkills: ["Communication","Organizational skills","Attention to detail","Problem-solving","Conflict management"]

Lead TMF operations for BBP-418 clinical trials by establishing TMF strategy, governance, and inspection readiness. Serve as the TMF Subject Matter Expert, driving TMF process improvements, managing TMF quality metrics and risks, and overseeing CRO performance. Collaborate cross-functionally to ensure timely document filing, issue resolution, and alignment with ICH-GCP, ALCOA+ standards, and good documentation practices while supporting continuous inspection readiness.

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FursaFursa
BridgeBio
BridgeBio
1 month ago

Associate Director, TMF Operations Lead

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Last checked: 3 hours agoStatus: Live

Job Summary

Lead TMF operations for BBP-418 clinical trials by establishing TMF strategy, governance, and inspection readiness. Serve as the TMF Subject Matter Expert, driving TMF process improvements, managing TMF quality metrics and risks, and overseeing CRO performance. Collaborate cross-functionally to ensure timely document filing, issue resolution, and alignment with ICH-GCP, ALCOA+ standards, and good documentation practices while supporting continuous inspection readiness.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Business Operations
Seniority: Director level

Key Responsibilities

  • •Lead TMF operations across assigned clinical studies to ensure timely, complete, and inspection-ready Trial Master File documentation.
  • •Establish TMF governance by monitoring TMF health, quality metrics, risk assessments, and inspection readiness; communicate key findings to teams and leadership.
  • •Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, and CRO TMF Oversight Plans.
  • •Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely filing and consistent execution.
  • •Oversee inspection readiness activities and CRO-managed TMF performance, including quality reviews, audit support, artifact retrieval, and CAPA development and follow-up.
Travel: High travel

Pay and Benefits

Salary: USD 191,000 - 220,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kEquityHsaFsaParental LeavePaid Leave

Key Requirements

  • •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 and experience handling clinical trial-related documents.
  • •Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents.
  • •Demonstrated ability to comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices.
  • •Proficiency with Microsoft Excel, Word, and PowerPoint, and familiarity with Smartsheet and SharePoint.
Experience:8+ yearsClinical trialsBiotechPharmaceuticals
Skills:CommunicationOrganizational skillsAttention to detailProblem-solvingConflict management
Languages:English
Tech Stack:ICH-GCPALCOA+Good Documentation PracticesTrial Master File Reference Model StructureCAPAMicrosoft ExcelMicrosoft WordMicrosoft PowerPointSmartsheetSharePoint

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn