Medical Director – Neuromuscular Clinical Development

BioSpace; Waltham (MA); On-site; USD 270,000 - 310,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA, is seeking a Medical Director, Clinical Development to lead DM1 program studies, ensure participant safety, and drive high-quality trial execution across investigators, CROs, and cross-functional teams. The role requires a Doctor of Medicine degree with 5+ years in clinical development, including medical monitoring, and a strong regulatory background.

You will collaborate with Regulatory Affairs, Biostatistics, Translational Medicine, and Clinical Operations,

Qualifications

• Doctor of Medicine degree; board certification or advanced training in neurology, neuroscience, neuromuscular disease, pediatrics, internal medicine, or a related specialty preferred, or other relevant degree
• 5+ years of relevant experience, with 3+ years of clinical development, medical monitoring, pharmacovigilance, clinical research, or related roles
• Experience serving as a medical monitor or providing medical oversight for interventional clinical trials
• Experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas preferred
• Strong understanding of clinical trial design, protocol execution, medical data review, safety monitoring, and clinical development processes
• Regulatory experience with FDA, EMA, ICH, GCP, and other applicable regulatory requirements for clinical trials
• Ability to travel as needed for investigator meetings, site engagement, advisory boards, congresses, and internal meetings

Responsibilities

• Contribute to planning, design, development, and implementation of clinical trials for assigned drug candidates
• Apply knowledge of disease mechanisms to support biomarker selection and endpoints
• Contribute to integrated product and clinical development plans and medical monitoring activities
• Provide medical input to cross-functional partners on decisions with clinical components
• Serve as medical monitor for assigned studies and review safety data

Skills

Medical monitoring

Clinical development

Regulatory submissions

Data interpretation

CRO/vendor management

Communication skills

Team leadership

Education

Doctor of Medicine degree

Job description

Dyne Therapeutics in Waltham, MA, is seeking a Medical Director, Clinical Development to lead DM1 program studies, ensure participant safety, and drive high-quality trial execution across investigators, CROs, and cross-functional teams. The role requires a Doctor of Medicine degree with 5+ years in clinical development, including medical monitoring, and a strong regulatory background.

You will collaborate with Regulatory Affairs, Biostatistics, Translational Medicine, and Clinical Operations,