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