Associate Director, TMF Lead

requirements and industry best practices. Serve as the TMF subject matter expert, establishing clear expectations for document structure, naming conventions, indexing, and lifecycle management. In partnership with Clinical Operations study lead, oversee TMF health across all studies, ensuring completeness, accuracy, and inspection readiness at all times through ongoing quality control and reconciliation. Lead TMF activities across the study lifecycle, including study start-up, maintenance, and close-out, ensuring proper documentation, completeness reviews, and archival readiness. Own and execute TMF migration efforts ensuring data integrity, completeness, and alignment with Kyverna standards. Assess and evaluate TMF system providers by defining

requirements, conducting vendor assessments, and leading cross-functional reviews to identify a compliant, scalable, and inspection-ready solution. Partner closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT and external partners to ensure seamless document flow and accountability. Operate comfortably in both strategy and execution, including direct involvement in document review, filing quality, and issue resolution. Establish TMF metrics and KPIs to proactively identify risks, drive continuous improvement, and ensure sustained inspection readiness. Support regulatory inspections and audits as the TMF lead, ensuring readiness and effective responses to health authority inquiries.

Qualifications Bachelor’s degree in life sciences or related field; advanced degree preferred. 10+ years of clinical research experience with a strong focus on TMF management. Proven experience leading TMF operations, including both strategic oversight and hands-on execution. Demonstrated experience transitioning TMF activities from outsourced to in-house models. Strong expertise in Veeva Vault eTMF, including implementation, migration, and ongoing management. Deep understanding of TMF structure, document taxonomy, and regulatory

requirements (FDA, EMA, ICH-GCP). Experience managing TMF across the full study lifecycle, including close-out and archival. Experience leading TMF migration initiatives with a focus on quality and compliance. Experience in biotech or cell and gene therapy. Experience supporting regulatory inspections and audits. Experience building or scaling TMF capabilities within a growing organization. The national salary range for this position is from $160,000 to $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for

bonus,

benefits, and participation in Company’s stock plan. Apply for this job Links Home Platform & Pipeline Patients Inside Kyverna Knowledge Center Investors Careers Contact About Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate mivocabtagene (miv-cel, KYV-101), is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff person syndrome, multiple sclerosis, and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna’s pipeline includes next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. FOLLOW US ON SOCIAL Privacy Policy (US) Privacy Policy (EU/UK) Designed by Elegant Themes | Powered by WordPress

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