Medical Director, Clinical Development

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 Contribute to the planning, design, development, and implementation of clinical trials for assigned drug candidatesApply knowledge of disease mechanisms to support selection and interpretation of biomarkers, pharmacodynamic and clinical endpoints, and patient stratification considerationsContribute to the development and implementation of effective, timely studies to establish the safety, tolerability, pharmacodynamic activity, and efficacy of assigned drug candidatesContribute to integrated product and clinical development plans, ensuring medical monitoring activities align with broader program objectivesProvide medical input to Research, Translational Medicine, Biomarkers, and other cross-functional partners on decisions with clinical components and implications Medical Monitoring, Safety, and Participant Oversight Serve as medical monitor for assigned studies, providing timely medical guidance to study teams, investigators, CROs, vendors, and advisorsReview clinical and safety data, eligibility questions, protocol deviations, adverse events, serious adverse events, and other medically relevant information to support participant safety and study integrityPartner with Pharmacovigilance and Clinical Development leadership to support safety surveillance, signal detection, benefit-risk assessment, and timely escalation of emerging safety concernsSupport study-level risk assessments, medical monitoring plans, data review plans, dose review discussions, and safety review meetings Clinical Study Execution and Vendor Oversight Collaborate with Clinical Operations to ensure assigned study activities are completed in accordance with applicable regulations, GCP, ICH guidelines, Dyne SOPs, and study timelinesEnsure compliance with applicable regulatory standards related to global clinical trials and interactions with physiciansSupport the development, implementation, and maintenance of SOPs for clinical trials and related activities, as requiredSupport site engagement, investigator training, enrollment strategy, medical issue resolution, and inspection readiness for assigned studiesPartner with Clinical Operations on outsourcing and in-house approaches for clinical development capabilities and implementation plansManage relationships with CROs, vendors, and external collaborative partners supporting clinical development efforts Data Review, Regulatory Support, and Scientific Deliverables Review and interpret emerging clinical, safety, biomarker, pharmacodynamic, and endpoint data to inform study conduct, program strategy, and regulatory interactionsContribute medical review and interpretation for protocols, investigator brochures, informed consent forms, clinical study reports, briefing materials, safety narratives, and regulatory responsesSupport regulatory submissions and interactions with health authorities by providing study-specific medical input and data interpretationRepresent the company in interactions with regulatory agencies, as requiredManage the writing, review, and accountability for key clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, regulatory submissions, abstracts, peer-reviewed articles, presentations, and publicationsSupport abstracts, presentations, publications, and other scientific communications, as appropriate External Engagement and Relationship Management Identify, manage, and interface with external collaborators, investigators, advisors, and key opinion leaders to support clinical development strategies for a novel class of therapeuticsDevelop and maintain professional relationships with academic and community-based study sitesParticipate, as requested, in Business Development due diligence, advisory boards, investigator meetings, and presentations to external constituencies Cross-Functional Leadership and Communication Maintain accountability for relevant timelines and deliverables in close partnership with functional counterparts and clinical development colleaguesCoordinate and communicate with internal departments and external vendors to ensure study objectives, timelines, and deliverables are accomplishedManage, coordinate, and provide ongoing assessment, evaluation, and communication with internal departments and external vendors to support successful study executionProvide timely updates to Clinical Development leadership and cross-functional partners on study progress, medical issues, emerging risks, changes in scope, schedule, and resourcesInterface with functions within and outside of R&D, including Finance, Regulatory Affairs, Legal, Commercial, and Medical AffairsProvide leadership and mentorship to clinical development team members, including matrixed team members and potential direct reports 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 degree5+ years of relevant experience, with 3+ years of clinical development, medical monitoring, pharmacovigilance, clinical research, or related roles within the pharmaceutical or biotechnology industryExperience serving as a medical monitor or providing medical oversight for interventional clinical trialsExperience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas preferredStrong understanding of clinical trial design, protocol execution, medical data review, safety monitoring, and clinical development processesWorking knowledge of FDA, EMA, ICH, GCP, and other applicable regulatory requirements for clinical trialsRegulatory experience with Pre-lNDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-USExperience reviewing and contributing to clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, clinical study reports, safety narratives, briefing materials, and regulatory responsesAbility to interpret clinical, safety, biomarker, pharmacodynamic, and efficacy data and translate findings into clear medical recommendationsStrong clinical judgment and ability to assess participant safety, protocol eligibility, adverse events, and medically complex study questionsDemonstrated ability to work effectively in a fast-paced, matrixed biotechnology environment with cross-functional partners and external vendorsStrong collaboration skills with the ability to influence without authority, build alignment, and drive practical solutions across teamsExcellent written, verbal, and presentation skills, with the ability to communicate complex medical and scientific information clearly to internal and external audiencesStrong attention to detail, organizational skills, and ability to manage multiple priorities while maintaining high-quality executionAbility to operate with appropriate independence, sound judgment, urgency, and accountabilityExperience working with CROs, investigators, study sites, and external experts preferredWillingness to be hands-on and contribute across strategic and executional activities in a growing clinical-stage biotechnology companyAbility to travel as needed for investigator meetings, site engagement, advisory boards, congresses, and internal meetings 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.