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Director, Clinical Scientist at Dyne Therapeutics
Waltham, MAFull-time1240GL - Clinical DevelopmentPosted about 1 month ago
Apply with PipelineAbout the 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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0">https://www.dyne-tx.com/</a>, and follow us on <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0">X</a>, <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0">LinkedIn</a> and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0">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="none">The Director, Clinical Scientist serves as a scientific and clinical development leader responsible for supporting the strategy, design, execution, interpretation, and communication of Dyne’s clinical studies. This role partners closely with the Clinical Development Lead and cross-functional teams to advance high-quality clinical programs for people living with rare, genetically driven neuromuscular diseases.</span> <span data-ccp-props="{}"> </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 Director-level role requires strong clinical development expertise, scientific judgment, and the ability to translate emerging clinical data into actionable insights that inform study conduct, program strategy, regulatory interactions, and external scientific communications. The Director contributes to clinical development plans, protocol strategy, study execution, data review, regulatory deliverables, investigator engagement, and internal and external data presentations.</span><span data-ccp-props="{}"> </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">The ideal candidate brings a collaborative, patient-focused mindset and can lead complex clinical science workstreams with independence, accountability, and cross-functional influence in a fast-paced, growing biotechnology environment.</span><span data-ccp-props="{}"> </span></p>
<p><strong>Primary Responsibilities Include:</strong></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 Development Strategy & Study Leadership:</span></span><span data-ccp-props="{"335559739":120}"> </span></em></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Serve as a clinical science lead or key clinical science contributor for assigned studies, partnering with </span></span><span data-contrast="none"><span data-ccp-parastyle="Body">the</span><span data-ccp-parastyle="Body"> study medical director</span><span data-ccp-parastyle="Body"> to support study strategy, design, execution, data interpretation, and reporting.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Provide scientific input into study design, patient population, eligibility criteria, endpoints, biomarkers, assessments, visit schedules, and data collection strategies to ensure trials are scientifically sound, operationally </span><span data-ccp-parastyle="Body">feasible</span><span data-ccp-parastyle="Body">, and aligned with program objectives.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Interpret emerging clinical data and translate findings into clear recommendations for study conduct, clinical development strategy, internal governance discussions, regulatory interactions, and external scientific communications.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Maintain current knowledge of rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, clinical trial innovation, regulatory expectations, competitive developments, and relevant scientific literature.</span></span><span data-ccp-props="{"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 data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="none"><span data-ccp-parastyle="Body">Clinical Trial Execution & Cross-Functional Collaboration:</span></span><span data-ccp-props="{"335559739":120}"> </span></em></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Partner closely with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, Quality, CROs, vendors, and other stakeholders to support high-quality study execution.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Monitor study progress, </span><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> scientific, clinical, operational, or data-related risks, and partner with cross-functional teams to define practical mitigation strategies that support quality, timelines, and patient safety.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Collaborate with Clinical Operations on oversight of study milestones and overall study metrics.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Represent Clinical Development on cross-functional study teams</span><span data-ccp-parastyle="Body">,</span><span data-ccp-parastyle="Body"> workstreams, and governance discussions, </span><span data-ccp-parastyle="Body">as assigned </span><span data-ccp-parastyle="Body">providing clear scientific input and influencing alignment without direct authority.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Collaborate with investigators, key opinion leaders, external experts, CROs, and vendors to support scientific exchange, study execution, issue resolution, and alignment with clinical development objectives.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Support Study Medical Monitor in overseeing CRO Medical Monitoring team, including review of meeting minutes, meeting materials, and support for medical monitoring deliverables.</span></span><span data-ccp-props="{"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 data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="none"><span data-ccp-parastyle="Body">Clinic</span><span data-ccp-parastyle="Body">al Data Review, Interpretation & Safety Oversight:</span></span><span data-ccp-props="{"335559739":120}"> </span></em></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Support ongoing patient-level and aggregate clinical data review, including safety, efficacy, biomarker, pharmacodynamic, endpoint, and protocol compliance data, to </span></span><span data-contrast="none"><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> trends, insights, risks, </span><span data-ccp-parastyle="Body">protocol deviations, safety trend review, </span><span data-ccp-parastyle="Body">patient profile </span><span data-ccp-parastyle="Body">review</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">and </span><span data-ccp-parastyle="Body">other </span><span data-ccp-parastyle="Body">potential issues.</span></span><span data-ccp-props="{"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 data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Partner with Pharmacovigilance and Clinical Development colleagues to support safety surveillance, signal evaluation, benefit-risk assessment, safety narratives, and </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> escalation of clinically meaningful findings.</span></span><span data-ccp-props="{"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 data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="none"><span data-ccp-parastyle="Body">Clinical and Regulatory Deliverables:</span></span><span data-ccp-props="{"335559739":120}"> </span></em></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Lead or contribute to the development of clinical study concepts, protocol synopses, protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, and other key clinical and regulatory deliverables.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Contribute to regulatory submissions and interactions by preparing, reviewing, and interpreting clinical content for INDs, CTAs, briefing books, annual reports, DSURs, submission dossiers, and responses to regulatory questions.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Support investigator meetings, site engagement, advisory boards, data monitoring committee materials, steering committee materials, and other internal or external scientific forums as needed.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Contribute to internal and external presentations, abstracts, posters, manuscripts, publications, and other scientific communications that summarize clinical data clearly and accurately.</span></span><span data-ccp-props="{"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 data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="none"><span data-ccp-parastyle="Body">Leadership, Mentorship & Dyne Culture:</span></span></em><span data-ccp-props="{"335559739":120}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Mentor, coach, or provide guidance to clinical scientists, study team members, or cross-functional colleagues as </span><span data-ccp-parastyle="Body">appropriate</span><span data-ccp-parastyle="Body">, helping strengthen clinical science capabilities and quality of execution.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Model Dyne’s core values and </span><span data-ccp-parastyle="Body">demonstrate</span><span data-ccp-parastyle="Body"> accountability, collaboration, urgency, integrity, scientific excellence, and commitment to patients in all internal and external interactions.</span></span></li>
</ul>
<p><strong>Education and Skills Requirements:</strong></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><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"]}">Advanced degree in life sciences, healthcare, pharmacy, medicine, nursing, or a clinically relevant discipline </span><span data-ccp-parastyle="Body">required</span><span data-ccp-parastyle="Body">; PhD, PharmD, MD, or equivalent advanced degree preferred.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">8+ years of relevant experience in clinical development, clinical science, clinical research, or related roles within the pharmaceutical or biotechnology industry.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Experience supporting or leading interventional clinical trials across multiple phases of development; experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas strongly preferred.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Experience supporting global, late-stage clinical trials and submissions.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Demonstrated understanding of clinical development strategy, study design, protocol development, regulatory documentation, data review, clinical trial execution, and study reporting.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Strong knowledge</span><span data-ccp-parastyle="Body"> and experience with</span><span data-ccp-parastyle="Body"> GCP, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements for clinical trials.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Experience developing or contributing to clinical and regulatory documents, including protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, abstracts, posters, and manuscripts.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Strong ability to interpret clinical, safety, biomarker, pharmacodynamic, efficacy, and endpoint data and translate findings into clear insights, recommendations, and communications.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Experience with clinical data review tools and systems, including EDC systems, data listings, patient profiles, dashboards, Excel, PowerPoint, and other tools used to support clinical data review, analysis, and reporting.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Demonstrated ability to lead complex clinical science workstreams, manage competing priorities, </span><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> risks, resolve issues, and drive deliverables in a fast-paced, matrixed biotechnology environment.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Strong cross-functional collaboration and influencing skills, with the ability to build alignment across Clinical Development, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, external vendors, and study sites.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific and clinical information clearly to internal and external audiences.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Strong scientific judgment, critical thinking, attention to detail, and problem-solving skills.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Ability to </span><span data-ccp-parastyle="Body">operate</span><span data-ccp-parastyle="Body"> with independence, sound judgment, accountability, urgency, and flexibility in a growing clinical-stage biotechnology company.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Experience working with CROs, investigators, study sites, key opinion leaders, advisory boards, or external experts preferred.</span></span></li>
<li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none"><span data-ccp-parastyle="Body">Ability to travel domestically and internationally for trial site visits, investigator meetings, advisory boards, scientific congresses, and internal meetings; approximately 20% travel.</span></span><span data-ccp-props="{}"> </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>$222,000</span><span class="divider">—</span><span>$258,000 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>
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