Associate Director, Trial Master File Lead

Overview Our commitment to people with neuromuscular diseases is our greatest strength. 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 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. Location: Waltham Role Title Associate Director, Trial Master File Lead Department: 1440GL - Clinical Operations 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. Primary Responsibilities TMF Strategy & Leadership: Define and own the company’s TMF strategy, including innovation opportunities and continuous improvement initiatives TMF operating models: Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals TMF subject matter expert: Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends Cross-functional representation: Represent TMF leadership in cross functional forums, governance committees, and senior level operational discussions Governance & Process Ownership Governance frameworks: Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards TMF lifecycle management: Oversee TMF lifecycle management—from planning and setup through closeout and archival Roles & responsibilities: Define TMF roles, responsibilities, and RACI structures across internal teams and vendors CAPAs: Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues Documentation: Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners TMF Oversight & Compliance Quality reviews & KPIs: Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs) Inspection readiness: Ensure TMFs across the portfolio remain inspection ready Audits & regulatory submissions: Lead TMF related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate Risk identification: Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities Vendor & Technology Management Vendor oversight: Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements eTMF optimization: Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations Contractual quality: Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF Industry trends: Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices Cross Functional Partnership & Support Study team collaboration: Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations Training & coaching: Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements Leadership readiness: Advise leadership on TMF health and organizational readiness for key regulatory events Education and Skills 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 ICH GCP, 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 Pay Range: MA Pay Range $155,000 — $190,000 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Apply for this job BACK | NEXT #J-18808-Ljbffr