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.
• Support investigator meetings, site engagement, advisory boards, data monitoring committee materials, steering committee materials, and other internal or external scientific forums as needed.
• Contribute to internal and external presentations, abstracts, posters, manuscripts, publications, and other scientific communications that summarize clinical data clearly and accurately. 

Leadership, Mentorship & Dyne Culture: 

• Mentor, coach, or provide guidance to clinical scientists, study team members, or cross-functional colleagues as appropriate, helping strengthen clinical science capabilities and quality of execution.
• Model Dyne’s core values and demonstrate accountability, collaboration, urgency, integrity, scientific excellence, and commitment to patients in all internal and external interactions.

Education and Skills Requirements:

• Advanced degree in life sciences, healthcare, pharmacy, medicine, nursing, or a clinically relevant discipline required; PhD, PharmD, MD, or equivalent advanced degree preferred.
• 8+ years of relevant experience in clinical development, clinical science, clinical research, or related roles within the pharmaceutical or biotechnology industry.
• Experience supporting or leading interventional clinical trials across multiple phases of development; experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas strongly preferred.
• Experience supporting global, late-stage clinical trials and submissions.
• Demonstrated understanding of clinical development strategy, study design, protocol development, regulatory documentation, data review, clinical trial execution, and study reporting.
• Strong knowledge and experience with GCP, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements for clinical trials.
• Experience developing or contributing to clinical and regulatory documents, including protocols, protocol amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, abstracts, posters, and manuscripts.
• Strong ability to interpret clinical, safety, biomarker, pharmacodynamic, efficacy, and endpoint data and translate findings into clear insights, recommendations, and communications.
• Experience with clinical data review tools and systems, including EDC systems, data listings, patient profiles, dashboards, Excel, PowerPoint, and other tools used to support clinical data review, analysis, and reporting.
• Demonstrated ability to lead complex clinical science workstreams, manage competing priorities, identify risks, resolve issues, and drive deliverables in a fast-paced, matrixed biotechnology environment.
• Strong cross-functional collaboration and influencing skills, with the ability to build alignment across Clinical Development, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Translational Medicine, Medical Affairs, external vendors, and study sites.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific and clinical information clearly to internal and external audiences.
• Strong scientific judgment, critical thinking, attention to detail, and problem-solving skills.
• Ability to operate with independence, sound judgment, accountability, urgency, and flexibility in a growing clinical-stage biotechnology company.
• Experience working with CROs, investigators, study sites, key opinion leaders, advisory boards, or external experts preferred.
• Ability to travel domestically and internationally for trial site visits, investigator meetings, advisory boards, scientific congresses, and internal meetings; approximately 20% travel. 

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