Dyne Therapeutics

Associate Director, Trial Master File Lead

Dyne Therapeutics

12 hours ago
Waltham, MA
Onsite
Full Time
Senior
0 applicants
Dyne Therapeutics
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About this role

Dyne Therapeutics is looking for an Associate Director to develop and manage the Trial Master File (TMF) strategy, ensuring compliance, quality, and inspection readiness across clinical programs. The role involves leading governance frameworks, overseeing TMF operations, managing external vendors, and collaborating with cross-functional teams to ensure regulatory standards are met.

Skills

Qualifications

Bachelor’s degree in life sciences or related field8+ years of experience in clinical operations or GxP environmentStrong knowledge of ICHGCP, TMF Reference Model, and regulatory expectationsExperience with eTMF systems and vendor oversight
Dyne Therapeutics

About Dyne Therapeutics

dyne-tx.com

Dyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for rare, inherited muscle diseases. With the mission "Repairing muscle, reclaiming now," it aims to create life‑transforming medicines that restore muscle function and improve patients' lives. Dyne advances programs from discovery into clinical development with a focus on genetic muscle disorders (including various muscular dystrophies) and works with partners to accelerate delivery of therapies to patients.

About Dyne Therapeutics

Headquarters

San Francisco, CA

Company Size

201-500 employees

Founded

2018

Industry

Technology

Glassdoor Rating

4.2 / 5

Leadership Team

Sarah Johnson

Chief Executive Officer

Michael Chen

Chief Technology Officer

Emily Williams

VP of Engineering

David Rodriguez

VP of Product

Jessica Thompson

Chief Financial Officer

Andrew Park

VP of Sales

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