Associate Director, TMF Operations

Role: Associate Director, TMF Lead, responsible for developing and executing Kyverna's in-house Trial Master File strategy to ensure inspection readiness and regulatory compliance across clinical studies. Responsibilities: lead end-to-end TMF setup and governance, oversee document quality, manage TMF lifecycle from start-up to close-out, lead migration efforts, evaluate and select TMF system vendors (notably Veeva Vault), and support regulatory audits. Collaborate closely with Clinical Operations, Regulatory, Quality, and IT teams to ensure seamless document flow and compliance. Requirements: Bachelor's in life sciences or related field; 10+ years in clinical research with extensive TMF expertise, including strategic oversight, hands-on management, and transition from outsourced to in-house models; deep knowledge of TMF structures, document taxonomy, and regulatory standards (FDA, EMA, ICH-GCP); proven experience with Veeva Vault and TMF migration projects; biotech or cell/gene therapy experience preferred. Work setup: Remote eligible; reports to Sr. Director, Clinical Operations.