Executive Director, Clinical Development - Neurology
Insmed Incorporated
August 20, 2026
Remote friendly (Bridgewater, NJ)
United States
Clinical Research and Development
Executive Director, Clinical Development – Neurology (Reports to VP, Clinical Development – Gene Therapy)
Responsibilities:
- Lead clinical programs across different diseases and supervise the clinical development team.
- Serve as primary point person for medical monitoring and oversight of assigned clinical programs: monitor clinical studies; review and interpret clinical trial data; author clinical study and regulatory communications/documents; monitor competitor activities and data.
- Design and implement clinical development strategy and clinical protocols; deliver high-quality clinical programs from first-in-human through full development.
- Therapeutic area lead for Neurology Gene therapy clinical development team; partner with clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
- Provide medical leadership for clinical operational strategy (site selection, enrollment, feasibility); escalate issues affecting study quality/integrity.
- Perform medical monitoring, coding, and data cleaning with Clinical Operations; ensure medical integrity of clinical study reports and data interpretation/communication.
- Author or oversee clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings (including Advisory Committee Meetings).
- Prepare safety charters/DMC charters and other management plans/manuals.
- Represent the company to external stakeholders (CROs, clinical consultants, investigational sites); organize SAB and DMC meetings.
- Maintain clinical/scientific expertise by reviewing literature and attending medical/scientific meetings; advise gene therapy leadership on strategic direction.
Qualifications:
- MD, DO, or foreign equivalent.
- 10+ years global experience in neurology clinical development (pharma/biotech).
- Experience across Phases 1–3.
- 5+ years management experience in clinical development.
- Prior Gene Therapy experience.
- Neurology residency training.
- Knowledge of ICH-GCP and FDA regulatory guidelines.
Nice to Have:
- PhD strongly preferred.
- Pediatric experience.
- Prior gene therapy drug approval experience.
Travel: ~20% occasional domestic/international.
Application: Current Insmed employees apply via Jobs Hub in Workday.
Responsibilities:
- Lead clinical programs across different diseases and supervise the clinical development team.
- Serve as primary point person for medical monitoring and oversight of assigned clinical programs: monitor clinical studies; review and interpret clinical trial data; author clinical study and regulatory communications/documents; monitor competitor activities and data.
- Design and implement clinical development strategy and clinical protocols; deliver high-quality clinical programs from first-in-human through full development.
- Therapeutic area lead for Neurology Gene therapy clinical development team; partner with clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
- Provide medical leadership for clinical operational strategy (site selection, enrollment, feasibility); escalate issues affecting study quality/integrity.
- Perform medical monitoring, coding, and data cleaning with Clinical Operations; ensure medical integrity of clinical study reports and data interpretation/communication.
- Author or oversee clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings (including Advisory Committee Meetings).
- Prepare safety charters/DMC charters and other management plans/manuals.
- Represent the company to external stakeholders (CROs, clinical consultants, investigational sites); organize SAB and DMC meetings.
- Maintain clinical/scientific expertise by reviewing literature and attending medical/scientific meetings; advise gene therapy leadership on strategic direction.
Qualifications:
- MD, DO, or foreign equivalent.
- 10+ years global experience in neurology clinical development (pharma/biotech).
- Experience across Phases 1–3.
- 5+ years management experience in clinical development.
- Prior Gene Therapy experience.
- Neurology residency training.
- Knowledge of ICH-GCP and FDA regulatory guidelines.
Nice to Have:
- PhD strongly preferred.
- Pediatric experience.
- Prior gene therapy drug approval experience.
Travel: ~20% occasional domestic/international.
Application: Current Insmed employees apply via Jobs Hub in Workday.