Associate Director, TMF Lead

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Position Overview

Kyverna is seeking an Associate Director, TMF Lead to lead the strategy, build, and execution of an in-house Trial Master File function. This role will play a critical part in advancing our clinical programs by ensuring all study TMFs are consistently inspection-ready and aligned with global regulatory expectations. This individual will operate as both a strategic leader and hands-on expert, responsible for transitioning electronic TMF operations from an outsourced model to an integrated, scalable in-house capability. The role requires deep expertise in TMF structure, document quality, and lifecycle management, along with strong ownership of systems, processes, and cross-functional alignment.

Title: Associate Director, TMF Lead

Location: Remote eligible

Reports To: Sr. Director, Clinical Operations

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.

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.