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
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
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.
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Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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