Description
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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. 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 Director, Clinical Scientist serves as a scientific and clinical development leader responsible for supporting the strategy, design, execution, interpretation, and communication of Dyne’s clinical studies. This role partners closely with the Clinical Development Lead and cross-functional teams to advance high-quality clinical programs for people living with rare, genetically driven neuromuscular diseases.
This Director-level role requires strong clinical development expertise, scientific judgment, and the ability to translate emerging clinical data into actionable insights that inform study conduct, program strategy, regulatory interactions, and external scientific communications. The Director contributes to clinical development plans, protocol strategy, study execution, data review, regulatory deliverables, investigator engagement, and internal and external data presentations.
The ideal candidate brings a collaborative, patient-focused mindset and can lead complex clinical science workstreams with independence, accountability, and cross-functional influence in a fast-paced, growing biotechnology environment.
Primary Responsibilities Include:
Clinical Development Strategy & Study Leadership:
- Serve as a clinical science lead or key clinical science contributor for assigned studies, partnering with the study medical director to support study strategy, design, execution, data interpretation, and reporting.
- Provide scientific input into study design, patient population, eligibility criteria, endpoints, biomarkers, assessments, visit schedules, and data collection strategies to ensure trials are scientifically sound, operationally feasible, and aligned with program objectives.
- Interpret emerging clinical data and translate findings into clear recommendations for study conduct, clinical development strategy, internal governance discussions, regulatory interactions, and external scientific communications.
- Maintain current knowledge of rare disease, neuromuscular disease, genetic medicine, oligonucleotide therapeutics, clinical trial innovation, regulatory expectations, competitive developments, and relevant scientific literature.
Clinical Trial Execution & Cross-Functional Collaboration:
- Partner closely with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, Quality, CROs, vendors, and other stakeholders to support high-quality study execution.
- Monitor study progress, identify scientific, clinical, operational, or data-related risks, and partner with cross-functional teams to define practical mitigation strategies that support quality, timelines, and patient safety.
- Collaborate with Clinical Operations on oversight of study milestones and overall study metrics.
- Represent Clinical Development on cross-functional study teams, workstreams, and governance discussions, as assigned providing clear scientific input and influencing alignment without direct authority.
- Collaborate with investigators, key opinion leaders, external experts, CROs, and vendors to support scientific exchange, study execution, issue resolution, and alignment with clinical development objectives.
- Support Study Medical Monitor in overseeing CRO Medical Monitoring team, including review of meeting minutes, meeting materials, and support for medical monitoring deliverables.
Clinical Data Review, Interpretation & Safety Oversight:
- Support ongoing patient-level and aggregate clinical data review, including safety, efficacy, biomarker, pharmacodynamic, endpoint, and protocol compliance data, to identify trends, insights, risks, protocol deviations, safety trend review, patient profile review and other potential issues.
- Partner with Pharmacovigilance and Clinical Development colleagues to support safety surveillance, signal evaluation, benefit-risk assessment, safety narratives, and timely escalation of clinically meaningful findings.
Clinical and Regulatory Deliverables:
- Lead or contribute to the development of clinical study concepts, protocol synopses, protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, and other key clinical and regulatory deliverables.
- Contribute to regulatory submissions and interactions by preparing, reviewing, and interpreting clinical content for INDs, CTAs, briefing books, annual reports, DSURs, submission dossiers, and responses to regulatory questions.
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