Dyne Therapeutics
Senior Director, Epidemiology and Real World Evidence
Waltham, MA · Director
Sponsorship not specified$245k-$300kDetected 21 days ago
Public HealthFDA RegulatoryPharmacovigilanceResearchExperimental DesignAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingEpidemiologyRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- 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.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- 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
- Provides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activities
- 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
- Builds and maintains relationships with external epidemiologists, academic collaborators, consortia, and patient registries
- 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
Requirements
- 15+ years of relevant experience in epidemiology, real world evidence, observational research, or related scientific disciplines
- 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
Nice to have
- Experience in rare diseases and/or neuromuscular disorders strongly preferred
Compensation
- $245,000 - $300,000 USD
Benefits
- 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
- Partners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance, signal evaluation, and benefit-risk assessment
- 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
- Strengthens epidemiology and RWE capabilities across Medical Affairs through training, mentorship, and knowledge sharing
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
Apply directly at Dyne Therapeutics →Create a free account for alerts like thisView Dyne Therapeutics immigration profile
This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.