Associate Director, TMF Operations
- Role
- Operations
- Experience
- Lead
- Employment
- Full-time
Open to US only. Set where you work from to check your eligibility.
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, TMFOperations 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 Operations Location: Remote eligible Reports To: Sr. Director, Clinical Operations
What you'll do
- Lead the strategy, build, and execution of an in-house Trial Master File function.
- Ensure all study TMFs are consistently inspection-ready and aligned with global regulatory expectations.
- Transition electronic TMF operations from an outsourced model to an integrated, scalable in-house capability.
What they require
- Deep expertise in TMF structure, document quality, and lifecycle management.
- Strong ownership of systems, processes, and cross-functional alignment.
Benefits
- Eligible for bonus
- Benefits
- Participation in Company’s stock plan
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases.