Medical Director, Neuromuscular Clinical Development

Dyne Tx; 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 patient safety, and provide medical input to study teams and vendors in compliance with GCP and ICH.

The role requires MD with 5+ years in clinical development, neuromuscular disease, and experience as a medical monitor; you will collaborate with Regulatory, Biostatistics, and Translational Medicine to advance therapeutic programs.

Qualifications

• Doctor of Medicine degree required and board certification or advanced training in neurology, neuroscience, neuromuscular disease, pediatrics, internal medicine, or related field.
• Minimum 5+ years in relevant clinical development roles within biotech/pharma, with emphasis on neuromuscular diseases.
• Experience as a medical monitor or medical oversight for interventional trials.
• Experience with regulatory submissions and interactions with health authorities.
• Strong ability to interpret complex clinical data and provide clear medical recommendations.
• Proven collaboration skills across cross-functional teams and external partners.
• Willingness to travel for investigator meetings, site engagement, and congresses.

Responsibilities

• Contribute to planning, design, and implementation of clinical trials for DM1 and other candidates.
• Provide medical monitoring, guidance, and risk mitigation for assigned studies.
• Review safety data, protocol deviations, and adverse events to protect participant safety and study integrity.
• Collaborate with Regulatory Affairs, Biostatistics, Translational Medicine, and others to support regulatory submissions.
• Develop SOPs for clinical trials and oversee site engagement, investigator training, and enrollment strategy.
• Manage relationships with CROs, vendors, and external collaborators supporting development efforts.
• Lead medical review of protocols, patient information materials, and regulatory submissions.

Skills

Medical knowledge

Clinical development

Neuromuscular disease

Regulatory/ICH/GCP

Leadership

Education

Doctor of Medicine (MD)

Job description

Dyne Therapeutics in Waltham, MA is seeking a Medical Director, Clinical Development to lead DM1 program studies, ensure patient safety, and provide medical input to study teams and vendors in compliance with GCP and ICH.

The role requires MD with 5+ years in clinical development, neuromuscular disease, and experience as a medical monitor; you will collaborate with Regulatory, Biostatistics, and Translational Medicine to advance therapeutic programs.