Medical Director, Clinical Development
Dyne Therapeutics
September 03, 2026
Full-time
Remote friendly (Waltham, MA)
Worldwide
Clinical Research and Development
Role: Medical Director, Clinical Development for neuromuscular diseases, focusing on DM1. Primary objectives include leading clinical trial execution, ensuring participant safety, and supporting the development strategy. Responsibilities encompass study design, medical monitoring, safety oversight, data review, regulatory interactions, and external stakeholder engagement. Collaborates closely with cross-functional teams such as Clinical Operations, Pharmacovigilance, Regulatory Affairs, and Translational Medicine, reporting to Clinical Development leadership. Location: Waltham, MA. Travel is expected as needed.
Qualifications: MD with board certification or advanced training in neurology or related fields; 5+ years relevant experience, including 3+ years in clinical development, medical monitoring, or pharmacovigilance within biotech or pharma. Experience in rare neuromuscular or genetic diseases, with knowledge of clinical trial design, GCP, ICH, FDA, EMA regulations, and regulatory submissions. Skills include strong medical judgment, data interpretation, collaboration, communication, and project management.
High-Value: Focus on neuromuscular disorders, rare diseases, biologics or gene therapies, clinical phases from IND through Phase 3, with oversight of safety, biomarkers, and regulatory documentation. The role involves external engagement with investigators, KOLs, and regulatory agencies, and leadership in a fast-paced, growth-stage biotech environment.
Qualifications: MD with board certification or advanced training in neurology or related fields; 5+ years relevant experience, including 3+ years in clinical development, medical monitoring, or pharmacovigilance within biotech or pharma. Experience in rare neuromuscular or genetic diseases, with knowledge of clinical trial design, GCP, ICH, FDA, EMA regulations, and regulatory submissions. Skills include strong medical judgment, data interpretation, collaboration, communication, and project management.
High-Value: Focus on neuromuscular disorders, rare diseases, biologics or gene therapies, clinical phases from IND through Phase 3, with oversight of safety, biomarkers, and regulatory documentation. The role involves external engagement with investigators, KOLs, and regulatory agencies, and leadership in a fast-paced, growth-stage biotech environment.