Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

The Medical Director, Clinical Development serves as a key member of the DM1 clinical development team and has primary responsibility for the execution of critical study(s) in the DM1 clinical program, which will include supporting the integrated development strategy. This role is responsible for ensuring participant safety, supporting high-quality study execution, interpreting emerging clinical and safety data, and providing timely medical input to study teams, investigators, vendors, and cross-functional partners. This role serves as the medical monitor on their assigned study(s), partnering closely with Clinical Development leadership, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, and other key stakeholders to support study design, protocol execution, medical review, data analysis, and regulatory deliverables. This individual will serve as the medical monitor for assigned studies, provide medical guidance on study conduct and risk mitigation, support responses to regulatory agency queries, and help ensure that clinical trials are conducted in accordance with GCP, ICH guidelines, applicable regulations, Dyne SOPs, and the highest standards of patient safety and scientific integrity.

This role is based in Waltham, MA.

Primary Responsibilities Include:

• Clinical Development Strategy and Study Design
• Medical Monitoring, Safety, and Participant Oversight
• Clinical Study Execution and Vendor Oversight
• Data Review, Regulatory Support, and Scientific Deliverables
• External Engagement and Relationship Management
• Cross-Functional Leadership and Communication

Education and Skills Requirements:

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 within the pharmaceutical or biotechnology industry.

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.

Working knowledge of FDA, EMA, ICH, GCP, and other applicable regulatory requirements for clinical trials.

Regulatory experience with Pre-lNDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US.

Experience reviewing and contributing to clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, clinical study reports, safety narratives, briefing materials, and regulatory responses.

Ability to interpret clinical, safety, biomarker, pharmacodynamic, and efficacy data and translate findings into clear medical recommendations.

Strong clinical judgment and ability to assess participant safety, protocol eligibility, adverse events, and medically complex study questions.

Demonstrated ability to work effectively in a fast-paced, matrixed biotechnology environment with cross-functional partners and external vendors.

Strong collaboration skills with the ability to influence without authority, build alignment, and drive practical solutions across teams.

Excellent written, verbal, and presentation skills, with the ability to communicate complex medical and scientific information clearly to internal and external audiences.

Strong attention to detail, organizational skills, and ability to manage multiple priorities while maintaining high-quality execution.

Ability to operate with appropriate independence, sound judgment, urgency, and accountability.

Experience working with CROs, investigators, study sites, and external experts preferred.

Willingness to be hands-on and contribute across strategic and executional activities in a growing clinical-stage biotechnology company.

Ability to travel as needed for investigator meetings, site engagement, advisory boards, congresses, and internal meetings.

#LI-Onsite

MA Pay Range

$270,000—$310,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.