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 and follow us on X LinkedInand 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 candidates
• Apply knowledge of disease mechanisms to support selection and interpretation of biomarkers pharmacodynamic and clinical endpoints and patient stratification considerations
• Contribute to the development and implementation of effective timely studies to establish the safety tolerability pharmacodynamic activity and efficacy of assigned drug candidates
• Contribute to integrated product and clinical development plans ensuring medical monitoring activities align with broader program objectives
• Provide 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 advisors
• Review clinical and safety data eligibility questions protocol deviations adverse events serious adverse events and other medically relevant information to support participant safety and study integrity
• Partner with Pharmacovigilance and Clinical Development leadership to support safety surveillance signal detection benefit-risk assessment and timely escalation of emerging safety concerns
• Support 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 timelines
• Ensure compliance with applicable regulatory standards related to global clinical trials and interactions with physicians
• Support the development implementation and maintenance of SOPs for clinical trials and related activities as required
• Support site engagement investigator training enrollment strategy medical issue resolution and inspection readiness for assigned studies
• Partner with Clinical Operations on outsourcing and in-house approaches for clinical development capabilities and implementation plans
• Manage 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 interactions
• Contribute medical review and interpretation for protocols investigator brochures informed consent forms clinical study reports briefing materials safety narratives and regulatory responses
• Support regulatory submissions and interactions with health authorities by providing study-specific medical input and data interpretation
• Represent the company in interactions with regulatory agencies as required
• Manage 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 publications
• Support 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 therapeutics
• Develop and maintain professional relationships with academic and community-based study sites
• Participate 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 colleagues
• Coordinate and communicate with internal departments and external vendors to ensure study objectives timelines and deliverables are accomplished
• Manage coordinate and provide ongoing assessment evaluation and communication with internal departments and external vendors to support successful study execution
• Provide timely updates to Clinical Development leadership and cross-functional partners on study progress medical issues emerging risks changes in scope schedule and resources
• Interface with functions within and outside of R&D including Finance Regulatory Affairs Legal Commercial and Medical Affairs
• Provide 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 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

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.