Associate Director, Trial Master File Lead

Responsibilities

• Define and own the company’s TMF strategy, including innovation and continuous improvement
• Lead the development and implementation of scalable TMF operating models
• Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends
• Establish and maintain TMF governance frameworks, including policies, SOPs, and quality standards
• Oversee TMF lifecycle management from planning through archival
• Monitor adherence to processes and drive corrective and preventive actions (CAPAs)
• Provide strategic oversight of TMF operations, including quality reviews and KPI assessments
• Ensure TMFs across the portfolio remain inspection ready
• Lead TMF-related preparation for audits, inspections, and regulatory submissions
• Oversee TMF service providers, CRO partners, and technology platforms
• Partner with IT to optimize eTMF systems, workflows, and integrations
• Provide training, coaching, and strategic direction to internal and external partners

Requirements

• Bachelor’s degree in life sciences or related field
• 8+ years of experience in clinical operations, document management, or GxP environments
• Significant TMF expertise
• Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations
• Proven experience developing TMF strategy or governance frameworks
• Experience working with eTMF systems and CRO/vendor oversight
• Excellent communication, influencing, and stakeholder management skills

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for FSHD and Pompe disease.