Dyne Therapeutics
Associate Director, Trial Master File Lead
Waltham, MA · Director
Sponsorship not specifiedDetected 21 days ago
Animal StudiesLeadershipMentoring
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- 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.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- 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
- 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
- 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
- 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
Nice to have
- Bachelor's degree in life sciences or related field
- advanced degree preferred
Skills
- Oversee TMF lifecycle management-from planning and setup through closeout and archival
- Define TMF roles, responsibilities, and RACI structures across internal teams and vendors
Benefits
- This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance
- Advise leadership on TMF health and organizational readiness for key regulatory events
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.