Associate Director, Trial Master File Lead

About this role

<div class="content-intro"><h3>Company Overview:</h3> <p>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 <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">The Associate Director, T</span><span data-ccp-parastyle="Normal (Web)">rial </span><span data-ccp-parastyle="Normal (Web)">M</span><span data-ccp-parastyle="Normal (Web)">aster </span><span data-ccp-parastyle="Normal (Web)">F</span><span data-ccp-parastyle="Normal (Web)">ile (TMF) Lead</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">is responsible for</span><span data-ccp-parastyle="Normal (Web)"> developing and driving the global TMF strategy, </span><span data-ccp-parastyle="Normal (Web)">establishing</span><span data-ccp-parastyle="Normal (Web)"> and maintaining robust governance frameworks, and ensuring end</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">to</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">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</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">quality clinical execution, and </span><span data-ccp-parastyle="Normal (Web)">operate</span><span data-ccp-parastyle="Normal (Web)"> efficiently at scale.</span><span data-ccp-parastyle="Normal (Web)"> This</span><span data-ccp-parastyle="Normal (Web)"> role</span><span data-ccp-parastyle="Normal (Web)"> partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance</span></span> <br> <br><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Primary Responsibilities</span><span data-ccp-parastyle="Normal (Web)"> Include</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">TMF Strategy & Leadership:</span></span><span…