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), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary

The Medical Director, Clinical Development serves as a key member of the DM1 clinical development team and has primary responsibility for the execution of critical study(s) in the DM1 clinical program, which will include supporting the integrated development strategy. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners. This role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This individual will serve as the medical monitor for assigned studies, provide medical guidance on study conduct and risk mitigation, support responses to regulatory agency queries, and help ensure that clinical trials are conducted in accordance with GCP, ICH guidelines, applicable regulations, Dyne SOPs, and the highest standards of patient safety and scientific integrity.

This role is based in Waltham, MA.

Primary Responsibilities Include

Clinical Development Strategy and Study Design

Contribute to the planning, design, development, and implementation of clinical trials for assigned drug candidates
Apply knowledge of disease mechanisms to support selection and interpretation of biomarkers, pharmacodynamic and clinical endpoints, and patient stratification considerations
Contribute to the development and implementation of effective, timely studies to establish the safety, tolerability, pharmacodynamic activity, and efficacy of assigned drug candidates
Contribute to integrated product and clinical development plans, ensuring medical monitoring activities align with broader program objectives
Provide medical input to Research, Translational Medicine, Biomarkers, and other cross-functional partners on decisions with clinical components and implications

Medical Monitoring, Safety, and Participant Oversight

Serve as medical monitor for assigned studies, providing timely medical guidance to study teams, investigators, CROs, vendors, and advisors
Review clinical and safety data, eligibility questions, protocol deviations, adverse events, serious adverse events, and other medically relevant information to support participant safety and study integrity
Partner with Pharmacovigilance and Clinical Development leadership to support safety surveillance, signal detection, benefit-risk assessment, and timely escalation of emerging safety concerns
Support study-level risk assessments, medical monitoring plans, data review plans, dose review discussions, and safety review meetings

Clinical Study Execution and Vendor Oversight

Collaborate with Clinical Operations to ensure assigned study activities are completed in accordance with applicable regulations, GCP, ICH guidelines, Dyne SOPs, and study timelines
Ensure compliance with applicable regulatory standards related to global clinical trials and interactions with physicians
Support the development, implementation, and maintenance of SOPs for clinical trials and related activities, as required