Associate Director, Medical Information and Review

Department: 4000GL - Medical AffairsLocation: Waltham, MACompany Overview: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 , and follow us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Medical Information and Review plays a critical role in building and executing Dyne’s Medical Information and medical review capabilities as the organization advances toward commercialization and launch readiness. This role serves as a key Medical Affairs partner in the review of promotional and non-promotional materials, ensuring scientific accuracy, medical integrity, fair balance, and alignment with applicable regulatory, legal, compliance, and company standards. The Associate Director also helps develop and maintain high-quality, scientifically balanced Medical Information content, supports inquiry management and vendor oversight, and translates medical inquiry trends, literature, and congress insights into actionable recommendations for internal stakeholders.This role is based in Waltham, MA.Primary Responsibilities Include:Serve as the core Medical Affairs reviewer within medical and promotional review processes, including Medical, Legal, and Regulatory review committees, ensuring scientific accuracy, integrity, fair balance, and appropriateness of promotional and non-promotional materialsEstablish and maintain thorough medical, scientific, clinical, disease-state, and product knowledge to serve as a primary Medical Information subject matter expert on Dyne’s product portfolio, with a focus on neuromuscular diseases and launch readiness prioritiesSupport Medical Information readiness for product launches and contribute to ongoing support and strategic management across all stages of the product lifecycle by building scalable processes, content libraries, training materials, workflows, and operational best practicesAssist with day-to-day operations, quality oversight, and vendor/contact center activities for Medical Information inquiry handling to provide high-quality service to external stakeholders, including case documentation, escalations, and response qualityAnalyze reports, metrics, inquiry trends, literature updates, and congress insights for Medical Information activities and communicate actionable insights to internal stakeholdersSupport and participate in congress activities, including execution of pre- and post-congress deliverables, insights gathering, internal readouts, and medical booth representationMaintain compliance with applicable FDA regulations, industry standards, organizational policies, and Medical Affairs best practices by ensuring all Medical Information and review initiatives are executed with the highest level of integrityProvide backup and operational support for the development and maintenance of Medical Information response documents addressing unsolicited inquiries from healthcare professionals and other stakeholdersPartner with Regulatory, Legal, Compliance, Commercial, Clinical Development, Scientific Communications, Pharmacovigilance, and other cross-functional stakeholders to support timely, compliant review and approval of materials and advance key organizational initiativesOperate with Associate Director-level ownership by leading multiple workstreams, facilitating collaboration, improving Medical Information operations, content governance, review processes, systems, SOPs, training, and inspection readiness in a fast-paced, matrixed biotech environmentEducation and Skills Requirements:Doctorate degree in a scientific or healthcare discipline required; PharmD, PhD, MD, or equivalent preferred8+ years of relevant experience including 5+ in Medical Information, medical review, medical communications, Medical Affairs, or a related function within the pharmaceutical, biotechnology, or healthcare industryExperience serving as a medical reviewer for promotional and non-promotional materials through Medical, Legal, Regulatory, and/or Promotional Review Committee processesStrong understanding of FDA regulations, industry guidance, and compliance expectations governing Medical Information, scientific exchange, promotional review, and non-promotional communicationsExperience developing, reviewing, and maintaining Medical Information response documents, FAQs, scientific summaries, or related medical/scientific contentAbility to interpret and communicate complex scientific and clinical data clearly, accurately, and appropriately for internal and external audiencesWell versed in medical literature searches, publication review, evidence assessment, and synthesis of scientific informationExperience supporting launch readiness, Medical Information operations, vendor/contact center oversight, congress activities, or inquiry trend analysis preferredRare disease, neuromuscular disease, or specialty biopharmaceutical experience preferredStrong project management, organizational, and process-building skills, with the ability to lead multiple workstreams and improve ways of workingExcellent written, verbal, and interpersonal communication skills, with demonstrated ability to collaborate, influence, and build trusted relationships across functionsHigh attention to detail, sound judgment, accountability, and commitment to compliance, scientific integrity, and Dyne’s mission and valuesAbility to work effectively in a fast-paced, matrixed biotechnology environment with evolving prioritiesWillingness to travel up to 25%, including scientific congresses and internal meetings as needed#LI-OnsiteMA Pay Range$150,000—$200,000 USDThe 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.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.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.BACK | NEXT