Senior Director, Epidemiology and Real World Evidence

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.

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
  • Pairs 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 Pharmacovigivalence activities
  • Pairs with Drug Safety/Pharmacovigivalence 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
  • Maintains awareness of 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/Pharmacovigivalence, 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