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. 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. #J-18808-Ljbffr Scorpion Therapeutics