Executive Director, Clinical Development - Neurology

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); elevate 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.

• 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.

• PhD strongly preferred.
• Pediatric experience.
• Prior gene therapy drug approval experience.

~20% occasional domestic/international.