Associate Director, TMF Operations

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, TMF Lead to develop and execute Kyverna's in-house Trial Master File strategy, ensuring inspection readiness and regulatory compliance across clinical studies.

The role oversees TMF governance, document quality, and lifecycle, while leading migrations and vendor assessments with close collaboration across Clinical Operations, Regulatory, Quality and IT. Remote eligible with reporting to Sr. Director, Clinical Operations.

Qualifications

• 10+ years in clinical research with extensive TMF expertise.
• Deep knowledge of TMF structures and regulatory standards (FDA, EMA, ICH-GCP).
• Proven experience with TMF migrations and in-house transition strategies.

Responsibilities

• Lead end-to-end TMF setup and governance.
• Oversee TMF document quality and lifecycle from start-up to close-out.
• Lead TMF migration efforts and evaluate TMF system vendors (notably Veeva Vault).
• Support regulatory audits and collaborate with Clinical Operations, Regulatory, Quality, and IT.

Skills

TMF governance

Regulatory compliance

Cross-functional leadership

Vendor management

Collaboration with cross functional

Education

Bachelor's degree in life sciences or related field

Tools

Veeva Vault

Job description

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)
• 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.