Senior Director, Epidemiology and Real World Evidence

Dyne Therapeutics•Waltham, MA

1d•$245,000 - $300,000•Onsite

About The Position

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.

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
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
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

Nice To Haves

Experience in rare diseases and/or neuromuscular disorders strongly preferred

Responsibilities

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
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
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
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