Senior Director, Epidemiology and Real World Evidence

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 and follow us on X LinkedInand Facebook.

Role Summary:

The Senior Director Epidemiology and Real World Evidence (RWE) is an enterprise expert in the application of epidemiology and realworld evidence to support Medical Affairsled scientific and clinical objectives. This role shapes and delivers rigorous RWE strategies that inform clinical decisionmaking advance disease and treatment understanding and enable highquality scientific engagement across the portfolio.

The role provides strategic leadership for interventional observational and epidemiologic research including Phase 3b and Phase 4 studies as well as prevalence and incidence studies to support endpoint development safety and pharmacovigilance regulatory interactions and medical decisionmaking. The Senior Director partners closely with Global Medical Directors HEOR Clinical Development Biometrics Drug Safety/Pharmacovigilance Regulatory Affairs Value & Access and Commercial to generate and interpret evidence that enables assetlevel Medical Affairs strategies. This position also strengthens epidemiology and RWE capabilities across Medical Affairs and Dyne through consistent standards governance and scientific excellence.

This role is based in Waltham MA.

Primary ResponsibilitiesInclude:

Strategic Leadership Governance & Enterprise Partnership

• Serves as Dynes scientific and methodological leader for interventional observational and epidemiologic research including Phase 3b Phase 4 and prevalence/incidence studies to address Medical Affairsdriven evidence needs across the portfolio
• Partners with Medical Affairs and HEOR to develop and execute an enterprise-level epidemiology and RWE strategy aligned with organizational objectives
• Establishes governance best practices and standards for epidemiologic and real world research across Medical Affairs
• Provides expert guidance to Global Medical Directors and cross-functional teams on the appropriate use interpretation and limitations of real world data
• Acts as an internal thought leader in epidemiology RWE and observational research methodologies

Epidemiology Observational & Interventional Research

• Leads the design execution and interpretation of epidemiologic and observational studies supporting Medical Affairs objectives including chart reviews post hoc analyses prospective observational studies investigator-initiated studies Phase 3b/4 studies and prevalence/incidence studies
• Partners with Clinical Development and Biometrics to inform endpoint development protocol design and external control strategies that address key evidence needs for clinical decision-making
• Ensures studies are scientifically rigorous fit-for-purpose compliant and publication-ready
• Oversees scientific dissemination through peer-reviewed publications congress presentations and external scientific engagement

Safety Pharmacovigilance & Regulatory Support

• Provides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activities
• Partners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance signal evaluation and benefitrisk assessment
• Designs and oversees post-authorization safety studies (PASS) registry-based safety evaluations observational safety studies and long-term safety assessments
• Supports evaluation of safety signals through background incidence rate analyses observed-to-expected analyses and other epidemiologic approaches
• Contributes epidemiologic expertise to risk management plans safety specifications and safety-related regulatory documentation as appropriate

Cross-Functional Collaboration Capability Building & Operational Excellence

• Collaborates with Global Medical Directors HEOR Regulatory Affairs Value & Access Commercial and other partners to support asset-level integrated evidence plans
• Engages with health authorities in collaboration with Regulatory Affairs on epidemiology- and RWE-related interactions
• Builds and maintains relationships with external epidemiologists academic collaborators consortia and patient registries
• Strengthens epidemiology and RWE capabilities across Medical Affairs through training mentorship and knowledge sharing
• Manages budgets timelines vendors and external partners to ensure quality compliance and operational excellence
• Monitors advances in real world data sources analytics and epidemiologic methods to drive innovation and continuous improvement

Educationand Skills Requirements:

• Advanced degree in epidemiology public health health services research or a related discipline
• 15 years of relevant experience in epidemiology real world evidence observational research or related scientific disciplines; or equivalent combination of education and experience
• Deep expertise in epidemiologic methods observational study design real world data sources and application of RWE to safety surveillance and pharmacovigilance
• Demonstrated experience leading post-authorization safety studies and contributing to regulatory documentation
• Proven ability to partner effectively across Medical Affairs Clinical Development Drug Safety/Pharmacovigilance HEOR Regulatory Affairs and Market Access in a matrix environment
• Strong track record of scientific communication peer-reviewed publication and external scientific engagement
• Experience in rare diseases and/or neuromuscular disorders strongly preferred
• Strong analytical strategic and problem-solving skills with the ability to operate as an enterprise expert and influence without authority
• Exceptional written verbal and presentation skills
• Willingness to travel up to approximately 30%
• High level of integrity ethics compliance and transparency with flexibility to adapt to evolving scientific and organizational needs
• Strong alignment with Dynes mission values and commitment to patients

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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.