Medical Director, Clinical Development — Neuromuscular

BioSpace; Waltham (MA); Presencial; USD 270.000 - 310.000; Jornada completa

Descripción de la vacante

Dyne Therapeutics seeks a Medical Director, Clinical Development to lead DM1 program studies and ensure high-quality trial execution with patient safety at the forefront.

You will monitor studies, review emerging data, and provide medical guidance to cross-functional teams, vendors, and regulators, ensuring compliance with GCP and applicable standards. Based in Waltham, MA, this role requires collaboration across Clinical Operations, Regulatory, Biostatistics, and Translational Medicine.

Formación

• MD with board certification or advanced training in neurology or related field.
• Minimum 5+ years in clinical development, medical monitoring, pharmacovigilance, or related roles.
• Experience as medical monitor for interventional clinical trials.
• Knowledge of FDA/EMA/ICH, GCP, and regulatory requirements.
• Ability to review and interpret clinical, safety, biomarker, pharmacodynamic, and efficacy data.
• Strong collaboration and communication skills; travel as needed.

Responsabilidades

• 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, and safety concerns.
• Partner with Pharmacovigilance and Clinical Development to support safety surveillance and risk mitigation.
• Support study-level risk assessments, monitoring plans, data review, and safety review meetings.
• Collaborate with Clinical Operations to ensure studies comply with GCP, ICH, and regulatory standards.
• Manage relationships with CROs, vendors, and external partners.

Conocimientos

Medical monitoring

Clinical trial design

Pharmacovigilance

Data interpretation

Regulatory affairs knowledge

Leadership

Educación

MD (Doctor of Medicine)

Board certification or advanced training in neurology/related

Descripción del empleo

Dyne Therapeutics seeks a Medical Director, Clinical Development to lead DM1 program studies and ensure high-quality trial execution with patient safety at the forefront.

You will monitor studies, review emerging data, and provide medical guidance to cross-functional teams, vendors, and regulators, ensuring compliance with GCP and applicable standards. Based in Waltham, MA, this role requires collaboration across Clinical Operations, Regulatory, Biostatistics, and Translational Medicine.