Director, Trial Master File
Kymera Therapeutics
June 25, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
How you’ll make an impact:
- Lead end-to-end implementation and configuration of the Trial Master File (TMF/eTMF) platform, including system setup, role-based access, workflows, and integration with clinical systems to ensure regulatory and inspection-readiness.
- Develop, standardize, and implement TMF business processes, SOPs, governance models, and operational workflows across clinical programs.
- Provide strategic and operational leadership for end-to-end TMF management across all clinical studies, ensuring inspection readiness.
- Serve as TMF subject matter expert; guide Clinical Operations, Regulatory, Quality, and study teams on document requirements and best practices.
- Lead oversight of eTMF systems and service providers, ensuring vendor performance and compliance.
- Establish and monitor TMF performance metrics and dashboards; identify risks and drive corrective actions.
- Integrate TMF activities into study planning and execution (start-up through close-out and inspection readiness).
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as central point of contact.
- Lead and execute TMF QC and periodic review activities, including completeness checks, root-cause analysis, and CAPA development.
- Define and drive TMF training and enablement for internal staff and vendors.
- Lead or contribute to continuous improvement initiatives for TMF quality and efficiency.
- Ensure timely and compliant TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical industry with TMF management and eTMF system implementation.
- Proven process improvement experience; clinical trial execution/sponsor oversight; TMF/eTMF strategy.
- Experience planning, managing, and overseeing activities/deliverables within Clinical Operations.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple concurrent programs/projects.
- Excellent analytical, problem-solving, organizational, and cross-functional communication skills.
- Demonstrated ability to lead change and foster continuous improvement.
Compensation:
- Anticipated base salary range: $195,000 – $275,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Lead end-to-end implementation and configuration of the Trial Master File (TMF/eTMF) platform, including system setup, role-based access, workflows, and integration with clinical systems to ensure regulatory and inspection-readiness.
- Develop, standardize, and implement TMF business processes, SOPs, governance models, and operational workflows across clinical programs.
- Provide strategic and operational leadership for end-to-end TMF management across all clinical studies, ensuring inspection readiness.
- Serve as TMF subject matter expert; guide Clinical Operations, Regulatory, Quality, and study teams on document requirements and best practices.
- Lead oversight of eTMF systems and service providers, ensuring vendor performance and compliance.
- Establish and monitor TMF performance metrics and dashboards; identify risks and drive corrective actions.
- Integrate TMF activities into study planning and execution (start-up through close-out and inspection readiness).
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as central point of contact.
- Lead and execute TMF QC and periodic review activities, including completeness checks, root-cause analysis, and CAPA development.
- Define and drive TMF training and enablement for internal staff and vendors.
- Lead or contribute to continuous improvement initiatives for TMF quality and efficiency.
- Ensure timely and compliant TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical industry with TMF management and eTMF system implementation.
- Proven process improvement experience; clinical trial execution/sponsor oversight; TMF/eTMF strategy.
- Experience planning, managing, and overseeing activities/deliverables within Clinical Operations.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple concurrent programs/projects.
- Excellent analytical, problem-solving, organizational, and cross-functional communication skills.
- Demonstrated ability to lead change and foster continuous improvement.
Compensation:
- Anticipated base salary range: $195,000 – $275,000; eligibility for annual bonus, equity participation, and comprehensive benefits.