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 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

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