Senior Director, Epidemiology and Real World Evidence (Waltham)

Department: 4000US - Medical Affairs - USLocation: 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 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, LinkedIn and Facebook.Role Summary:The Senior Director, Epidemiology and Real World Evidence (RWE) is an enterprise expert in the application of epidemiology and real‑world evidence to support Medical Affairs–led scientific and clinical objectives. This role shapes and delivers rigorous RWE strategies that inform clinical decision‑making, advance disease and treatment understanding, and enable high‑quality 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 decision‑making. 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 asset‑level 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 Responsibilities Include: Strategic Leadership, Governance & Enterprise PartnershipServes as Dyne’s scientific and methodological leader for interventional, observational, and epidemiologic research, including Phase 3b, Phase 4, and prevalence/incidence studies, to address Medical Affairs–driven evidence needs across the portfolioPartners with Medical Affairs and HEOR to develop and execute an enterprise-level epidemiology and RWE strategy aligned with organizational objectivesEstablishes governance, best practices, and standards for epidemiologic and real world research across Medical AffairsProvides expert guidance to Global Medical Directors and cross-functional teams on the appropriate use, interpretation, and limitations of real world dataActs as an internal thought leader in epidemiology, RWE, and observational research methodologiesEpidemiology, Observational & Interventional ResearchLeads 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 studiesPartners with Clinical Development and Biometrics to inform endpoint development, protocol design, and external control strategies that address key evidence needs for clinical decision-makingEnsures studies are scientifically rigorous, fit-for-purpose, compliant, and publication-readyOversees scientific dissemination through peer-reviewed publications, congress presentations, and external scientific engagementSafety, Pharmacovigilance & Regulatory SupportProvides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activitiesPartners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance, signal evaluation, and benefit–risk assessmentDesigns and oversees post-authorization safety studies (PASS), registry-based safety evaluations, observational safety studies, and long-term safety assessmentsSupports evaluation of safety signals through background incidence rate analyses, observed-to-expected analyses, and other epidemiologic approachesContributes epidemiologic expertise to risk management plans, safety specifications, and safety-related regulatory documentation, as appropriateCross-Functional Collaboration, Capability Building & Operational ExcellenceCollaborates with Global Medical Directors, HEOR, Regulatory Affairs, Value & Access, Commercial, and other partners to support asset-level integrated evidence plansEngages with health authorities in collaboration with Regulatory Affairs on epidemiology- and RWE-related interactionsBuilds and maintains relationships with external epidemiologists, academic collaborators, consortia, and patient registriesStrengthens epidemiology and RWE capabilities across Medical Affairs through training, mentorship, and knowledge sharingManages budgets, timelines, vendors, and external partners to ensure quality, compliance, and operational excellenceMonitors advances in real world data sources, analytics, and epidemiologic methods to drive innovation and continuous improvement Education and Skills Requirements: Advanced degree in epidemiology, public health, health services research, or a related discipline15+ years of relevant experience in epidemiology, real world evidence, observational research, or related scientific disciplines; or equivalent combination of education and experienceDeep expertise in epidemiologic methods, observational study design, real world data sources, and application of RWE to safety surveillance and pharmacovigilanceDemonstrated experience leading post-authorization safety studies and contributing to regulatory documentationProven ability to partner effectively across Medical Affairs, Clinical Development, Drug Safety/Pharmacovigilance, HEOR, Regulatory Affairs, and Market Access in a matrix environmentStrong track record of scientific communication, peer-reviewed publication, and external scientific engagementExperience in rare diseases and/or neuromuscular disorders strongly preferredStrong analytical, strategic, and problem-solving skills with the ability to operate as an enterprise expert and influence without authorityExceptional written, verbal, and presentation skillsWillingness to travel up to approximately 30%High level of integrity, ethics, compliance, and transparency, with flexibility to adapt to evolving scientific and organizational needsStrong alignment with Dyne’s mission, values, and commitment to patients#LI-OnsiteMA Pay Range$245,000—$300,000 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