Kyverna - Associate Director, TMF Lead
Requirements
• 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.
Responsibilities
• Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations, ensuring control, scalability, and quality across all clinical studies. • Define and implement TMF governance, processes, and standards to ensure consistent document organization, classification, and filing in alignment with regulatory 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.
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