Director, Trial Master File
Kymera Therapeutics
August 08, 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.
- Serve as the TMF subject matter expert; guide Clinical Operations, Regulatory, Quality, and cross-functional study teams on essential document requirements and best practices.
- Lead oversight of eTMF systems and service providers (vendor performance, contractual compliance, and sponsor expectations).
- Establish and monitor TMF performance metrics and dashboards (e.g., completeness, timeliness, quality trends) and drive corrective actions.
- Partner with Clinical Operations and study teams to integrate TMF activities from start-up through close-out and inspection readiness.
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as a central point of contact during TMF-related inspections.
- Lead TMF QC and periodic review activities, including completeness checks, quality issues, root-cause analysis, and CAPA development.
- Define and drive TMF training and enablement for internal staff and vendors.
- Ensure alignment between TMF practices and clinical trial oversight, vendor oversight, and protocol deviation management.
- Lead/contribute to continuous improvement initiatives; ensure timely TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical industry with direct TMF management and eTMF system implementation.
- Proven track record in process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
- Experience planning, managing, and overseeing Clinical Operations deliverables.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple projects/programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Demonstrated ability to lead change and foster continuous improvement.
- 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.
- Serve as the TMF subject matter expert; guide Clinical Operations, Regulatory, Quality, and cross-functional study teams on essential document requirements and best practices.
- Lead oversight of eTMF systems and service providers (vendor performance, contractual compliance, and sponsor expectations).
- Establish and monitor TMF performance metrics and dashboards (e.g., completeness, timeliness, quality trends) and drive corrective actions.
- Partner with Clinical Operations and study teams to integrate TMF activities from start-up through close-out and inspection readiness.
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as a central point of contact during TMF-related inspections.
- Lead TMF QC and periodic review activities, including completeness checks, quality issues, root-cause analysis, and CAPA development.
- Define and drive TMF training and enablement for internal staff and vendors.
- Ensure alignment between TMF practices and clinical trial oversight, vendor oversight, and protocol deviation management.
- Lead/contribute to continuous improvement initiatives; ensure timely TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical industry with direct TMF management and eTMF system implementation.
- Proven track record in process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
- Experience planning, managing, and overseeing Clinical Operations deliverables.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple projects/programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Demonstrated ability to lead change and foster continuous improvement.