Associate Director, Medical Information and Review

About the role

Company 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 https://www.dyne-tx.com/, 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.

Responsibilities

• 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 materials
• Establish 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 priorities
• Support 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 practices
• Assist 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 quality
• Analyze reports, metrics, inquiry trends, literature updates, and congress insights for Medical Information activities and communicate actionable insights to internal stakeholders
• Support and participate in congress activities, including execution of pre- and post-congress deliverables, insights gathering, internal readouts, and medical booth representation
• Maintain 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 integrity
• Provide backup and operational support for the development and maintenance of Medical Information response documents addressing unsolicited inquiries from healthcare professionals and other stakeholders
• Partner 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 initiatives
• Operate with Associate Director-level ownership by leading multiple workstre