Hiring: Medical Director, Clinical Development Company: Dyne Therapeutics Location: Waltham, MA Job Posted Time: 2026-09-10 13:16:41 Target Skills & Keywords : GCP, R About the job Experience: •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 Required Skills: •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. 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 •In-depth knowledge of clinical trial design, protocol execution, medical data review, safety monitoring, and clinical development processes •Solid functional 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 •Demonstrated capacity 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 Compensation: •$270,000 - $310,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!