Director, Trial Master File

Who We Are

: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.

Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. com or follow us on X (formerly Twitter) or LinkedIn . 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 + 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.

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. , 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.

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.

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.