Senior Director, Medical Information

<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><br>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"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Times New Roman",469777842,"Times New Roman",469777843,"Arial Unicode MS",469777844,"Times New Roman",469769226,"Times New Roman,Arial Unicode MS",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">The </span><span data-ccp-charstyle="normaltextrun">Senior </span><span data-ccp-charstyle="normaltextrun">Director, Medical </span><span data-ccp-charstyle="normaltextrun">Information</span><span data-ccp-charstyle="normaltextrun"> </span><span data-ccp-charstyle="normaltextrun">is responsible for</span><span data-ccp-charstyle="normaltextrun"> </span><span data-ccp-charstyle="normaltextrun">establishing</span><span data-ccp-charstyle="normaltextrun"> and leading the medical information function to ensure </span><span data-ccp-charstyle="normaltextrun">timely</span><span data-ccp-charstyle="normaltextrun">, </span><span data-ccp-charstyle="normaltextrun">accurate</span><span data-ccp-charstyle="normaltextrun">, balanced, and compliant scientific responses to unsolicited inquiries from healthcare professional</span><span data-ccp-charstyle="normaltextrun">s</span><span data-ccp-charstyle="normaltextrun">. This role plays a critical part in supporting the safe and </span><span data-ccp-charstyle="normaltextrun">appropriate use</span><span data-ccp-charstyle="normaltextrun"> of the company’s products by delivering high-quality medical information and enabling scientific exchange. The </span><span data-ccp-charstyle="normaltextrun">person in this role </span><span data-ccp-charstyle="normaltextrun">has strong scientific </span><span data-ccp-charstyle="normaltextrun">expertise</span><span data-ccp-charstyle="normaltextrun">, experience in regulated environments, and the ability to build scalable medical information processes in a biotech setting.</span></span><span data-ccp-props="{"335559739":120}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><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"]}">This position is based in Waltham, MA, with the option to work remotely.</span></span> <br> <br><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Primary Responsibilities</span><span data-ccp-parastyle="Body"> Include</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Establish and lead the medical information function, including strategy, processes, and execution</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Oversee </span><span data-ccp-parastyle="Body">the implementation</span><span data-ccp-parastyle="Body"> and training</span><span data-ccp-parastyle="Body"> of </span><span data-ccp-parastyle="Body">the medical inquiry intake portal and call center vendors and manage </span><span data-ccp-parastyle="Body">relationships </span><span data-ccp-parastyle="Body">going forward</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders)</span><span data-ccp-parastyle="Body"> and </span><span data-ccp-parastyle="Body">maintain</span><span data-ccp-parastyle="Body"> medical information content aligned with product labeling, clinical data, and evolving scientific evidence</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead and oversee </span><span data-ccp-parastyle="Body">Medical, Legal, and Regulatory (</span><span data-ccp-parastyle="Body">MLR</span><span data-ccp-parastyle="Body">)</span><span data-ccp-parastyle="Body"> review </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ensure responses are scientifically </span><span data-ccp-parastyle="Body">accurate</span><span data-ccp-parastyle="Body">, balanced, up-to-date, and compliant with regulation</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ensure </span><span data-ccp-parastyle="Body">appropriate escalation</span><span data-ccp-parastyle="Body"> and coordination of safety, quality, and off-label inquiries</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Analyze inquiry trends to </span><span data-ccp-parastyle="Body">identify</span><span data-ccp-parastyle="Body"> knowledge gaps, unmet medical needs, and opportunities to inform medical strategy</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Monitor metrics and quality indicators to ensure continuous improvement and compliance</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 and Skills Requirements:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Doctorate degree (MD, PhD, PharmD) with </span><span data-ccp-parastyle="Body">1</span><span data-ccp-parastyle="Body">5</span><span data-ccp-parastyle="Body">+</span><span data-ccp-parastyle="Body"> years of experience </span><span data-ccp-parastyle="Body">in</span><span data-ccp-parastyle="Body"> </span><span data-ccp-parastyle="Body">medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Experience </span><span data-ccp-parastyle="Body">establishing</span><span data-ccp-parastyle="Body"> or leading a medical information function is strongly preferred</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Strong understanding of regulatory, compliance, and pharmacovigilance requirements</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Excellent scientific writing and verbal communication skills</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Strong organizational and process-building capabilities</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">High attention to detail and commitment to compliance and scientific integrity</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ability to work effectively in a matrixed, fast-paced biotech environment</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Strong judgment in handling complex or sensitive inquiries</span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$230,000</span><span class="divider">—</span><span>$285,000 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>