Medical Director, Clinical Development

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

 

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