Associate Director, Trial Master File Lead

Dyne Therapeutics•Waltham, MA

6d•$155,000 - $190,000

About The Position

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, Trial Master File (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

Requirements

Bachelor’s degree in life sciences or related field; advanced degree preferred
8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise
Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations
Proven experience developing TMF strategy, governance frameworks, or enterprise level processes
Ability to lead cross-functionally without authority Demonstrated leadership in managing TMF operations or oversight at a portfolio level
Experience working with eTMF systems and CRO/vendor oversight
Excellent communication, influencing, and stakeholder management skills

Responsibilities

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 regulatory requirements related to TMF management and documentation practices
Cross Functional Partnership & Support:
Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations
Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements
Advise leadership on TMF health and organizational readiness for key regulatory events