Director, Clinical Scientist
About The Position
The Director, Clinical Scientist is a scientific and clinical development leader who supports the strategy, design, execution, interpretation, and communication of Dyne Therapeutics’ clinical studies. Working closely with the Clinical Development Lead and cross-functional teams, this role advances high-quality clinical programs for people living with rare, genetically driven neuromuscular diseases. The Director applies clinical development expertise and scientific judgment to translate emerging clinical data into actionable insights for study conduct, program strategy, regulatory interactions, and scientific communications. The role contributes to clinical development plans, protocol strategy, study execution, data review, regulatory deliverables, investigator engagement, and internal and external data presentations. The position is based in Waltham, Massachusetts. The Director serves as clinical science lead or a key contributor for assigned studies, partners with the study medical director, and works with internal teams, CROs, vendors, investigators, key opinion leaders, and external experts. Responsibilities include supporting study design and execution; interpreting safety, efficacy, biomarker, pharmacodynamic, endpoint, and compliance data; identifying and mitigating risks; supporting safety surveillance and benefit-risk assessment; and leading or contributing to clinical and regulatory documents and scientific communications. The role may mentor clinical scientists and colleagues and is expected to model Dyne’s values, including accountability, collaboration, urgency, integrity, scientific excellence, and commitment to patients.
Requirements
- Advanced degree in life sciences, healthcare, pharmacy, medicine, nursing, or a clinically relevant discipline.
- At least 8 years of relevant experience in clinical development, clinical science, clinical research, or related roles in the pharmaceutical or biotechnology industry.
- Experience supporting or leading interventional clinical trials across multiple phases of development.
- Experience supporting global, late-stage clinical trials and submissions.
- Understanding of clinical development strategy, study design, protocol development, regulatory documentation, data review, trial execution, and study reporting.
- Strong knowledge and experience with GCP, ICH guidelines, FDA, EMA, and other applicable global clinical trial regulatory requirements.
- Experience developing or contributing to clinical and regulatory documents, including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, abstracts, posters, and manuscripts.
- 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, and PowerPoint.
- 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, including the ability to build alignment across internal functions, vendors, and study sites.
- Excellent written, verbal, and presentation skills, including the ability to communicate complex scientific and clinical information to internal and external audiences.
- Strong scientific judgment, critical thinking, attention to detail, and problem-solving skills.
- Ability to work independently with sound judgment, accountability, urgency, and flexibility in a growing clinical-stage biotechnology company.
- Ability to travel domestically and internationally for trial site visits, investigator meetings, advisory boards, scientific congresses, and internal meetings; approximately 20% travel.
Nice To Haves
- PhD, PharmD, MD, or equivalent advanced degree.
- Experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas.
- Experience working with CROs, investigators, study sites, key opinion leaders, advisory boards, or external experts.
Responsibilities
- Serve as clinical science lead or key clinical science contributor for assigned studies, partnering with the study medical director on study strategy, design, execution, data interpretation, and reporting.
- Provide scientific input on study design, patient population, eligibility criteria, endpoints, biomarkers, assessments, visit schedules, and data collection strategies.
- Interpret emerging clinical data and make recommendations for study conduct, clinical development strategy, governance discussions, regulatory interactions, and scientific communications.
- Maintain current knowledge of rare and neuromuscular diseases, genetic medicines, oligonucleotide therapeutics, trial innovation, regulatory expectations, competitive developments, and relevant scientific literature.
- Partner with cross-functional teams, CROs, vendors, and other stakeholders to support high-quality study execution.
- Monitor study progress, identify scientific, clinical, operational, or data-related risks, and help define mitigation strategies that support quality, timelines, and patient safety.
- Collaborate with Clinical Operations on study milestones and overall study metrics.
- Represent Clinical Development on cross-functional study teams, workstreams, and governance discussions, providing scientific input and influencing alignment.
- 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 the Study Medical Monitor in overseeing the CRO Medical Monitoring team, including reviewing meeting minutes and materials and supporting medical monitoring deliverables.
- Support ongoing patient-level and aggregate review of safety, efficacy, biomarker, pharmacodynamic, endpoint, and protocol-compliance data; identify trends, insights, risks, protocol deviations, and potential issues.
- Partner with Pharmacovigilance and Clinical Development colleagues on safety surveillance, signal evaluation, benefit-risk assessment, safety narratives, and escalation of clinically meaningful findings.
- Lead or contribute to clinical study concepts, protocol synopses, protocols, amendments, informed consent forms, investigator brochures, clinical study reports, briefing documents, regulatory responses, and other clinical and regulatory deliverables.
- Prepare, review, and interpret 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 scientific forums.
- Contribute to presentations, abstracts, posters, manuscripts, publications, and other communications that clearly and accurately summarize clinical data.
- Mentor, coach, or guide clinical scientists, study team members, or cross-functional colleagues as appropriate.
- Model Dyne’s core values and demonstrate accountability, collaboration, urgency, integrity, scientific excellence, and commitment to patients.
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What This Job Offers
Job Type
Full-time
Career Level
Director
