Associate Director, TMF Lead

Role Overview

• 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 ongoing quality control and reconciliation.
• Lead TMF activities across the study lifecycle, including study start-up, maintenance, and close-out, ensuring proper documentation, completeness reviews, and archival readiness.
• Own and execute TMF migration efforts ensuring data integrity, completeness, and alignment with Kyverna standards.
• Assess and evaluate TMF system providers by defining requirements, conducting vendor assessments, and leading cross-functional reviews to identify a compliant, scalable, and inspection-ready solution.
• Partner closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT and external partners to ensure seamless document flow and accountability.
• Operate comfortably in both strategy and execution, including direct involvement in document review, filing quality, and issue resolution.
• Establish TMF metrics and KPIs to proactively identify risks, drive continuous improvement, and ensure sustained inspection readiness.
• Support regulatory inspections and audits as the TMF lead, ensuring readiness and effective responses to health authority inquiries.

Requirements

• 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.

Tech Stack

• Google Cloud Platform
• Vault