Associate Director, Medical Information and Review

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 onXLinkedInandFacebook.

Role Summary:

The Associate Director Medical Information and Review plays a critical role in building and executing Dynes 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 materials
• Establish and maintain thorough medical scientific clinical disease-state and product knowledge to serve as a primary Medical Information subject matter expert on Dynes 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 workstreams facilitating collaboration improving Medical Information operations content governance review processes systems SOPs training and inspection readiness in a fast-paced matrixed biotech environment

Education and Skills Requirements:

• Doctorate degree in a scientific or healthcare discipline required; PharmD PhD MD or equivalent preferred
• 8 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 industry
• Experience serving as a medical reviewer for promotional and non-promotional materials through Medical Legal Regulatory and/or Promotional Review Committee processes
• Strong understanding of FDA regulations industry guidance and compliance expectations governing Medical Information scientific exchange promotional review and non-promotional communications
• Experience developing reviewing and maintaining Medical Information response documents FAQs scientific summaries or related medical/scientific content
• Ability to interpret and communicate complex scientific and clinical data clearly accurately and appropriately for internal and external audiences
• Well versed in medical literature searches publication review evidence assessment and synthesis of scientific information
• Experience supporting launch readiness Medical Information operations vendor/contact center oversight congress activities or inquiry trend analysis preferred
• Rare disease neuromuscular disease or specialty biopharmaceutical experience preferred
• Strong project management organizational and process-building skills with the ability to lead multiple workstreams and improve ways of working
• Excellent written verbal and interpersonal communication skills with demonstrated ability to collaborate influence and build trusted relationships across functions
• High attention to detail sound judgment accountability and commitment to compliance scientific integrity and Dynes mission and values
• Ability to work effectively in a fast-paced matrixed biotechnology environment with evolving priorities
• Willingness to travel up to 25% including scientific congresses and internal meetings as needed

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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.

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.