Senior Manager, Clinical Supply

<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-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">The Senior Manager Clinical Supply manages, and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. In addition, the role supports readiness of the clinical label and pack set up, global trial distribution network and clinical trial systems for upcoming clinical studies. </span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215,"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-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">The Senior Manager closely interfaces Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Organization (CMO), Contract Research Operations (CRO’s) and clinical sites to ensure clinical trial supply material is available as required and readiness of the clinical supply network work support the clinical trial strategy. The clinical supply team also provides critical input to set the clinical trial strategy. </span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215,"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-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none">This is a full-time position based in Waltham, MA</span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215,"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-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none">Primary Responsibilities Include:</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215,"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="none"><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"]}">Clinical Trial Supply</span></span></em><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Oversee clinical supply operations, including labeling, packaging, distribution, and resupply across global depots</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Manage depot and site inventory in collaboration with Trial Managers; ensure </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> IMP and placebo shipments globally</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Coordinate labeling and packaging activities with Clinical CMOs and </span><span data-ccp-parastyle="Body">monitor</span><span data-ccp-parastyle="Body"> international shipping and distribution</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Manage exceptions in Quality Systems (deviations, investigations, CAPAs, specifications, and change controls)</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ensure readiness of labeling, packaging, and distribution networks for future trials</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Align with Supply Planning on demand forecasts, manufacturing outputs, and supply continuity; reconcile inventory and shipments monthly</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead development and updates of pharmacy manuals for Phase I–III trials; provide input to clinical strategy and study protocols</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Manage product returns, replacements, and destruction in collaboration with Clinical Operations and Quality</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Identify</span><span data-ccp-parastyle="Body"> and implement process improvements; act as SME during regulatory audits</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Represent Clinical Supply on global project teams and collaborate cross-functionally to build capabilities</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Author and </span><span data-ccp-parastyle="Body">maintain</span><span data-ccp-parastyle="Body"> SOPs and work instructions for inventory, IRT, labeling, distribution, returns, and destruction</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="none"><span data-ccp-parastyle="Body">Network Logistics Support</span></span></em><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Coordinate shipments between CMOs, warehouses, 3PLs, test labs, and other nodes</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Support network resupply with internal teams and external partners (couriers, customs brokers, CMOs)</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ensure compliant, </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> shipments including documentation, booking, tracking, and closure</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Troubleshoot </span><span data-ccp-parastyle="Body">logistics</span><span data-ccp-parastyle="Body"> issues and implement corrective actions</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="none"><span data-ccp-parastyle="Body">Education</span><span data-ccp-parastyle="Body">, Experience, </span><span data-ccp-parastyle="Body">and Skills Requirements:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="auto">BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">5+ years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Experience leading contract manufacturing is required.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Excellent interpersonal and organizational skills.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Ability to work and influence across different functions and stakeholders</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">High collaborative team-player who fosters open communication, facilitates mutual understanding, drives alignment and effectively maintains relationships with key internal and external stakeholders.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Proven ability to manage external vendors</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Operational experience managing material movements across global CMOs, 3PLs, warehouses, and Test Labs.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Proactive problem solver and self-directed individual with the ability to operate independently in a complex, fast-paced environment.</span><span data-ccp-props="{"335559739":160,"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></li> <li><span data-contrast="auto">Ability to set clear objectives, effectively plan, prioritize, and anticipate challenges and drive execution per plan. </span><span data-ccp-props="{"335559739":160,"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></li> </ul> <p> </p> <p> </p> <p>#LI-Onsite</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$143,000</span><span class="divider">—</span><span>$175,000 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>