Director, Clinical Scientist

• 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.

Clinic al 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.

• 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.

• 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.

• 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.

#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.