Associate Director, Trial Master File Lead

dynetherapeutics

Waltham, MA · Waltham · United States

Posted Mar 10, 2026

Other
1440GL - Clinical Operations

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Job description

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. 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

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 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

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 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

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.