Medical Director, Clinical Development
Dyne Therapeutics
August 13, 2026
On-site
Waltham, MA
Clinical Research and Development
Medical Director, Clinical Development (DM1)
Primary Responsibilities
- Contribute to planning, design, development, and implementation of clinical trials for assigned drug candidates.
- Use disease mechanism knowledge to select/interpret biomarkers, pharmacodynamic and clinical endpoints, and patient stratification.
- Develop and implement timely studies to establish safety, tolerability, pharmacodynamic activity, and efficacy.
- Support integrated product/clinical development plans and ensure medical monitoring aligns with program objectives.
- Provide medical input to cross-functional partners (Research, Translational Medicine, Biomarkers).
- Serve as medical monitor for assigned studies; provide medical guidance to study teams, investigators, CROs, vendors, and advisors.
- Review clinical/safety data, eligibility questions, protocol deviations, AEs/SAEs to ensure participant safety and study integrity.
- Partner on safety surveillance, signal detection, benefit-risk assessment, and escalation of emerging safety concerns.
- Support study risk assessments, medical/data review plans, dose review discussions, and safety review meetings.
- Collaborate with Clinical Operations to ensure studies follow regulations, GCP/ICH, and SOPs; support site engagement and investigator training.
- Review and interpret clinical, safety, biomarker, pharmacodynamic, and endpoint data; support regulatory interactions and medical document review.
- Manage writing/review accountability for key clinical/regulatory documents (protocols, IBs, consent forms, reports, submissions, abstracts/presentations/publications).
- Interface with external collaborators/investigators/advisors and maintain relationships with study sites; participate in due diligence/advisory/investigator meetings.
- Provide leadership/mentorship and coordinate timelines/deliverables across functions and vendors.
Qualifications
- MD; board certification or advanced training preferred in neurology/neuroscience/neuromuscular disease/pediatrics/internal medicine or related specialty.
- 5+ years relevant experience; 3+ years in clinical development, medical monitoring, pharmacovigilance, clinical research, or related industry roles.
- Experience as medical monitor/providing oversight for interventional trials.
- Working knowledge of FDA/EMA/ICH/GCP and regulatory requirements.
- Regulatory experience with Pre-INDs, INDs, CTAs, EOP2 meetings, and NDA/BLAs/MAA (US and ex-US).
Preferred/Additional Skills
- Experience in rare disease/neuromuscular disease/genetic medicines/oligonucleotide therapeutics or other complex areas.
- Strong understanding of clinical trial design, protocol execution, medical data review, safety monitoring.
- Ability to interpret clinical/safety/biomarker/pharmacodynamic/efficacy data and make medical recommendations.
- Strong clinical judgment; ability to work in fast-paced matrixed environments; influence without authority.
- Excellent written, verbal, and presentation skills; strong organization and attention to detail.
- Experience working with CROs, investigators, study sites, and external experts.
- Willingness to be hands-on; travel as needed.
Location
- Waltham, MA.
Primary Responsibilities
- Contribute to planning, design, development, and implementation of clinical trials for assigned drug candidates.
- Use disease mechanism knowledge to select/interpret biomarkers, pharmacodynamic and clinical endpoints, and patient stratification.
- Develop and implement timely studies to establish safety, tolerability, pharmacodynamic activity, and efficacy.
- Support integrated product/clinical development plans and ensure medical monitoring aligns with program objectives.
- Provide medical input to cross-functional partners (Research, Translational Medicine, Biomarkers).
- Serve as medical monitor for assigned studies; provide medical guidance to study teams, investigators, CROs, vendors, and advisors.
- Review clinical/safety data, eligibility questions, protocol deviations, AEs/SAEs to ensure participant safety and study integrity.
- Partner on safety surveillance, signal detection, benefit-risk assessment, and escalation of emerging safety concerns.
- Support study risk assessments, medical/data review plans, dose review discussions, and safety review meetings.
- Collaborate with Clinical Operations to ensure studies follow regulations, GCP/ICH, and SOPs; support site engagement and investigator training.
- Review and interpret clinical, safety, biomarker, pharmacodynamic, and endpoint data; support regulatory interactions and medical document review.
- Manage writing/review accountability for key clinical/regulatory documents (protocols, IBs, consent forms, reports, submissions, abstracts/presentations/publications).
- Interface with external collaborators/investigators/advisors and maintain relationships with study sites; participate in due diligence/advisory/investigator meetings.
- Provide leadership/mentorship and coordinate timelines/deliverables across functions and vendors.
Qualifications
- MD; board certification or advanced training preferred in neurology/neuroscience/neuromuscular disease/pediatrics/internal medicine or related specialty.
- 5+ years relevant experience; 3+ years in clinical development, medical monitoring, pharmacovigilance, clinical research, or related industry roles.
- Experience as medical monitor/providing oversight for interventional trials.
- Working knowledge of FDA/EMA/ICH/GCP and regulatory requirements.
- Regulatory experience with Pre-INDs, INDs, CTAs, EOP2 meetings, and NDA/BLAs/MAA (US and ex-US).
Preferred/Additional Skills
- Experience in rare disease/neuromuscular disease/genetic medicines/oligonucleotide therapeutics or other complex areas.
- Strong understanding of clinical trial design, protocol execution, medical data review, safety monitoring.
- Ability to interpret clinical/safety/biomarker/pharmacodynamic/efficacy data and make medical recommendations.
- Strong clinical judgment; ability to work in fast-paced matrixed environments; influence without authority.
- Excellent written, verbal, and presentation skills; strong organization and attention to detail.
- Experience working with CROs, investigators, study sites, and external experts.
- Willingness to be hands-on; travel as needed.
Location
- Waltham, MA.