Director, Trial Master FileKymera Therapeutics • Boston, Massachusetts, United States
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Director, Trial Master File
Kymera Therapeutics
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
About
How we work
PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
COLLABORATE: We value trust and transparency from everyone. Our goals are shared, our decisions data‑driven and our camaraderie genuine.
BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
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 compliance with regulatory and inspection‑readiness standards.
Develop, standardize, and implement TMF business processes, SOPs, governance models, and operational workflows across clinical programs, partnering with Clinical Operations, Quality, Regulatory, and IT teams to drive consistent adoption, process efficiency, and scalable execution.
Provide strategic and operational leadership for the end‑to‑end management of the Trial Master File (TMF) across all clinical studies, ensuring inspection readiness throughout the trial lifecycle.
Serve as the TMF subject‑matter expert for the organization, providing guidance to Clinical Operations, Regulatory, Quality, and cross‑functional study teams on essential document requirements and best practices.
Lead oversight of eTMF systems and service providers, ensuring vendor performance, compliance with contractual obligations, and alignment with sponsor expectations for TMF management.
Establish and monitor TMF performance metrics and dashboards (e.g., completeness, timeliness, quality trends), proactively identifying risks and driving corrective actions.
Partner closely with Clinical Operations and study teams to ensure TMF activities are integrated into study planning and execution, from study start‑up through close‑out and inspection readiness.
Ensure TMF readiness to support audits, inspections, and regulatory submissions, acting as a central point of contact during TMF‑related inspection activities.
Lead and execute TMF QC and periodic review activities, including oversight of completeness checks, quality issues, root‑cause analysis, and CAPA development.
Define and drive TMF training and enablement for internal staff and vendors, ensuring consistent understanding of filing responsibilities and expectations.
Maintain alignment between TMF practices and clinical trial oversight, vendor oversight, and protocol deviation management, ensuring documentation supports sponsor oversight obligations.
Lead or contribute to continuous improvement initiatives to enhance TMF quality, efficiency, and inspection readiness, including process simplification and system optimization.
Ensure timely and compliant TMF close‑out, transfer, and archival, including oversight of final reconciliation activities and long‑term record retention requirements.
Skills and experience you’ll bring
10+ years of experience in the biotech/pharmaceutical industry with direct experience in TMF management and eTMF system implementation.
Proven track record in process improvement, clinical trial execution/sponsor oversight, and TMF/eTMF strategy.
Experience with planning, management, and oversight of activities and deliverables within Clinical Operations.
Strong understanding of clinical trial management, ICH‑GCP, and regulatory compliance.
Proven track record of managing multiple projects and/or programs concurrently.
Excellent analytical, problem‑solving, and organizational skills.
Strong communication and interpersonal skills with the ability to influence cross‑functional stakeholders.
Demonstrated ability to lead change and foster a culture of continuous improvement.
Equal Employment Opportunity Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance‑driven pay.
The anticipated base salary range for this role is $195,000 – $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.
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Languages
- English
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