Associate Director, Trial Master File Lead

<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 data-ccp-props="{"335559685":360,"335559739":120}"> </span></em></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Define and own the company’s TMF strategy,</span><span data-ccp-parastyle="Body"> including</span><span data-ccp-parastyle="Body"> innovation opportunities and continuous improvement initiatives</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Represent TMF leadership in cross</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">functional forums, governance committees, and senior</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">level operational discussions</span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto"><span data-ccp-parastyle="Body">Governance & Process Ownership:</span></span><span data-ccp-props="{"335559685":360,"335559739":120}"> </span></em></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Oversee TMF lifecycle management—from planning and setup through </span><span data-ccp-parastyle="Body">closeout</span><span data-ccp-parastyle="Body"> and archival</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Define TMF roles, responsibilities, and RACI structures across internal teams and vendors</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Ensure </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> collection, review, and management of TMF documents from </span><span data-ccp-parastyle="Body">clinical</span><span data-ccp-parastyle="Body"> study teams and external partners </span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto"><span data-ccp-parastyle="Body">TMF Oversight & Compliance:</span></span><span data-ccp-props="{"335559685":360,"335559739":120}"> </span></em></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs</span><span data-ccp-parastyle="Body">)</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Ensure TMFs across the portfolio remain inspection</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">ready </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Lead TMF</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">related preparation for audits, inspections, and regulatory submissions</span><span data-ccp-parastyle="Body">, ensuring all documentation is complete and </span><span data-ccp-parastyle="Body">accurate</span><span data-ccp-parastyle="Body"> </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Analyze TMF metrics and trends to proactively </span><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> risks, gaps, and improvement opportunities</span><span data-ccp-parastyle="Body"> to implement proactively</span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto"><span data-ccp-parastyle="Body">Vendor & Technology Management:</span></span><span data-ccp-props="{"335559685":360,"335559739":120}"> </span></em></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Partner with IT and business stakeholders to </span><span data-ccp-parastyle="Body">optimize</span><span data-ccp-parastyle="Body"> the eTMF system, workflows, and integrations</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices </span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto"><span data-ccp-parastyle="Body">Cross</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">Functional Partnership & Support:</span></span><span data-ccp-props="{"335559685":360,"335559739":120}"> </span></em></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Collaborate with </span><span data-ccp-parastyle="Body">cross-functional study teams</span><span data-ccp-parastyle="Body"> to guide TMF planning, milestones, and document management expectations</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Advise</span><span data-ccp-parastyle="Body"> leadership on TMF health and organizational readiness for key regulatory events</span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="auto"><span data-ccp-parastyle="Body">Education and Skills Requirements:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="auto">Bachelor’s degree in life sciences or related field; advanced degree preferred</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Proven experience developing TMF strategy, governance frameworks, or enterprise level processes</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Ability to lead cross-functionally without authority Demonstrated leadership in managing TMF operations or oversight at a portfolio level</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Experience working with eTMF systems and CRO/vendor oversight</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Excellent communication, influencing, and stakeholder management skills</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$155,000</span><span class="divider">—</span><span>$190,000 USD</span></div></div></div><div class="content-conclusion"><p> </p> <p>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.</p> <p>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.</p> <p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">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.</span></em></p></div>