Medical Director, Clinical Development – DM1 Lead

Dyne Therapeutics; Waltham (MA); Vor Ort; USD 270.000 - 310.000; Vollzeit

Zusammenfassung

Dyne Therapeutics, based in Waltham, MA, is seeking a Medical Director, Clinical Development to lead medical monitoring for the DM1 program, ensure patient safety, and guide study design and regulatory responses. You will partner with Clinical Development, Regulatory, Biostatistics, and Operations to oversee trials, review emerging data, and maintain GCP compliance.

5+ years in clinical development and neuromuscular disease experience preferred.

Qualifikationen

• Doctor of Medicine degree and medical license; board certification or advanced training preferred.
• 5+ years in clinical development, medical monitoring, pharmacovigilance, or related roles.
• Experience as medical monitor or oversight for interventional trials.
• Experience in rare diseases/neuromuscular genetic medicine is preferred.
• Strong understanding of trial design, safety data review, and regulatory processes.

Aufgaben

• Act as medical monitor for assigned studies, guiding teams and vendors.
• Review safety data and protocol deviations to protect participant safety.
• Support regulatory interactions with medical input and data interpretation.
• Collaborate with Clinical Operations to ensure compliant trial conduct.
• Lead medical input for development plans and safety review meetings.

Kenntnisse

Medical monitoring

Regulatory strategy

Clinical development

Cross-functional collaboration

Ausbildung

Doctor of Medicine

Jobbeschreibung

Dyne Therapeutics, based in Waltham, MA, is seeking a Medical Director, Clinical Development to lead medical monitoring for the DM1 program, ensure patient safety, and guide study design and regulatory responses. You will partner with Clinical Development, Regulatory, Biostatistics, and Operations to oversee trials, review emerging data, and maintain GCP compliance.

5+ years in clinical development and neuromuscular disease experience preferred.