Director, Trial Master File
Kymera Therapeutics
August 30, 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 setup, role-based access, workflows, and integration with clinical systems.
- 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 for document requirements and best practices.
- Oversee eTMF systems and service providers, ensuring vendor performance and contractual/compliance alignment.
- Establish and monitor TMF performance metrics and dashboards; identify risks and drive corrective actions.
- Partner with Clinical Operations and study teams to integrate TMF into study planning and execution (start-up through close-out).
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as inspection point of contact.
- Lead/execute TMF QC and periodic reviews (completeness checks, quality issues, root-cause analysis, CAPA).
- Define and drive TMF training and enablement for internal staff and vendors.
- Maintain alignment between TMF practices and trial oversight, including vendor oversight and protocol deviation management.
- Lead/participate in continuous improvement for TMF quality, efficiency, and inspection readiness.
- Ensure timely, compliant TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years biotech/pharma experience with direct TMF management and eTMF implementation.
- Proven process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
- Clinical Operations activity/deliverables planning, management, and oversight experience.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Experience managing multiple programs/projects concurrently.
- Strong analytical, problem-solving, and organizational skills.
- Strong communication and stakeholder influence.
- 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 setup, role-based access, workflows, and integration with clinical systems.
- 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 for document requirements and best practices.
- Oversee eTMF systems and service providers, ensuring vendor performance and contractual/compliance alignment.
- Establish and monitor TMF performance metrics and dashboards; identify risks and drive corrective actions.
- Partner with Clinical Operations and study teams to integrate TMF into study planning and execution (start-up through close-out).
- Ensure TMF readiness for audits, inspections, and regulatory submissions; act as inspection point of contact.
- Lead/execute TMF QC and periodic reviews (completeness checks, quality issues, root-cause analysis, CAPA).
- Define and drive TMF training and enablement for internal staff and vendors.
- Maintain alignment between TMF practices and trial oversight, including vendor oversight and protocol deviation management.
- Lead/participate in continuous improvement for TMF quality, efficiency, and inspection readiness.
- Ensure timely, compliant TMF close-out, transfer, and archival.
Skills and experience you’ll bring:
- 10+ years biotech/pharma experience with direct TMF management and eTMF implementation.
- Proven process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
- Clinical Operations activity/deliverables planning, management, and oversight experience.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Experience managing multiple programs/projects concurrently.
- Strong analytical, problem-solving, and organizational skills.
- Strong communication and stakeholder influence.
- 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.