Associate Director, TMF Lead

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 clinical programs by ensuring study TMFs are consistently inspection-ready and aligned with global regulatory expectations.

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.
• Oversee TMF health across all studies, ensuring completeness, accuracy, and inspection readiness through ongoing quality control.

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.

About Kyverna:

• Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases.
• The company is committed to transforming the future of treatment for autoimmune disease with a focus on innovation and collaboration.