Director, Drug Safety & Pharmacovigilance Scientist at Dyne Therapeutics

<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&nbsp;<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&amp;data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&amp;reserved=0">https://www.dyne-tx.com/</a>, and follow us on&nbsp;<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&amp;data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&amp;reserved=0">X</a>,&nbsp;<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&amp;data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&amp;reserved=0">LinkedIn</a>&nbsp;and&nbsp;<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&amp;data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&amp;reserved=0">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p> <p></p> <div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">The Director, Drug Safety &amp; Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne’s development programs. This role characterizes and communicates the safety profiles of investigational therapies, contributes to regulatory safety strategies and submissions, and ensures pharmacovigilance activities are conducted in compliance with applicable global regulations and company procedures. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making. The role applies expert scientific judgment to complex safety data, drives continuous improvement of pharmacovigilance processes, and contributes to a culture focused on patient safety, scientific excellence, and operational rigor.</div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">&nbsp;</div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">This position is based in Waltham, MA.</div> </div> <p><strong>Primary Responsibilities Include:</strong></p> <p></p> <div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Safety Surveillance, Signal Detection &amp; Risk Management</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Review, analyze, and interpret safety information from clinical studies, individual case safety reports (ICSRs), nonclinical studies, scientific literature, and other relevant sources.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Support medical and scientific review of ICSRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.</li> </ul> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Safety Reporting, Documentation &amp; Regulatory Support</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical study reports, integrated safety summaries, briefing documents, and regulatory submissions.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Prepare and present safety data, analyses, recommendations, and risk management strategies to cross-functional teams and governance committees.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Maintain complete, accurate, and inspection-ready documentation of safety surveillance activities, safety decisions, and associated deliverables.</li> </ul> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Cross-Functional Leadership &amp; Safety Governance</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Participate in safety governance forums and cross-functional program teams, providing scientific insight and recommendations to support decision-making.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Influence safety-related discussions across development programs through clear communication of complex safety data and benefit-risk considerations.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Foster a culture of collaboration, accountability, scientific excellence, and continuous improvement across Drug Safety &amp; Pharmacovigilance and the broader organization.</li> </ul> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Pharmacovigilance Operations, Compliance &amp; Continuous Improvement</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Develop, maintain, and enhance pharmacovigilance SOPs, work instructions, templates, and processes in alignment with global regulatory requirements and industry best practices.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Provide pharmacovigilance training and guidance to internal colleagues and cross-functional partners on safety surveillance, reporting requirements, documentation practices, and inspection readiness.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Support pharmacovigilance vendor oversight activities, including review of deliverables, quality assessments, issue escalation, and process improvements.</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Monitor evolving pharmacovigilance regulations, guidance, and industry standards and implement appropriate process enhancements to ensure continued compliance and operational effectiveness</li> </ul> </div> <p><strong>Education and Skills Requirements:</strong></p> <ul> <li>Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline required; MD, PharmD, PhD, or equivalent advanced degree preferred.</li> <li>10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience.</li> <li>Demonstrated expertise in safety surveillance, signal detection, signal evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage development programs.</li> <li>Experience authoring or contributing to DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related sections of clinical or regulatory documents.</li> <li>Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements.</li> <li>Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations.</li> <li>Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and pharmacovigilance vendor oversight practices.</li> <li>Demonstrated ability to apply sound scientific and medical judgment to complex safety information and communicate implications effectively to diverse stakeholders.</li> <li>Strong analytical, problem-solving, technical writing, presentation, and project management skills.</li> <li>Ability to manage multiple priorities and deliver high-quality work in a dynamic, fast-paced environment.</li> <li>Proven success collaborating within matrixed organizations and influencing stakeholders without direct authority.</li> <li>Strong attention to detail, accountability, integrity, and commitment to patient safety.</li> <li>Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology is preferred.</li> </ul> <p>#LI-Onsite</p> <p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$220,000</span><span class="divider">&mdash;</span><span>$240,000 USD</span></div></div></div><div class="content-conclusion"><p>&nbsp;</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.&nbsp; 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>