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Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn  and Facebook . Role Summary: The Associate Director, T rial  M aster  F ile (TMF) Lead   is responsible for  developing and driving the global TMF strategy,  establishing  and maintaining robust governance frameworks, and ensuring end   to   end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high   quality clinical execution, and  operate  efficiently at scale.  This  role  partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance     Primary Responsibilities  Include :   TMF Strategy & Leadership:   Define and own the company’s TMF strategy,  including  innovation opportunities and continuous improvement initiatives   Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals   Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends   Represent TMF leadership in cross   functional forums, governance committees, and senior   level operational discussions   Governance & Process Ownership:   Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards   Oversee TMF lifecycle management—from planning and setup through  closeout  and archival   Define TMF roles, responsibilities, and RACI structures across internal teams and vendors   Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues   Ensure  timely  collection, review, and management of TMF documents from  clinical  study teams and external partners    TMF Oversight & Compliance:   Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs )   Ensure TMFs across the portfolio remain inspection   ready    Lead TMF   related preparation for audits, inspections, and regulatory submissions , ensuring all documentation is complete and  accurate     Analyze TMF metrics and trends to proactively  identify  risks, gaps, and improvement opportunities  to implement proactively   Vendor & Technology Management:   Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements   Partner with IT and business stakeholders to  optimize  the eTMF system, workflows, and integrations   Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF   Stay up to date with industry trends and