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

• 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.