Senior Director, Epidemiology and Real World Evidence

Senior Director, Epidemiology and Real World Evidence

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Department: 4000US - Medical Affairs - US

Location: Waltham, MA

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) 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.

Location

This role is based in Waltham, MA.

Primary Responsibilities

Strategic Leadership, Governance & Enterprise Partnership

• Serves 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 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 benefit–risk 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

Education and 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 Dyne’s mission, values, and commitment to patients

Compensation

MA Pay Range $245,000 — $300,000 USD. 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.

Other

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.