Executive Director, Clinical Development - Neurology

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 240,000 - 360,000; Full time

Job summary

Scorpion Therapeutics is seeking an Executive Director of Clinical Development – Neurology to lead and advance gene therapy programs across diseases. You will supervise the clinical development team, oversee medical monitoring, and drive strategy from first-in-human through full development, collaborating with operations, regulatory, and commercial teams.

The role requires MD/DO with 10+ years in neurology clinical development, genetic therapy experience, and a strong regulatory track record;

Qualifications

• MD/DO or foreign equivalent required; neurology residency completed.
• 10+ years global experience in neurology clinical development (pharma/biotech).
• Experience across Phases 1–3 and 5+ years of management.
• Prior gene therapy experience and knowledge of ICH-GCP and FDA guidelines.

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.
• Design and implement clinical development strategy and protocols; deliver high-quality programs.
• Therapeutic area lead for Neurology Gene therapy development; partner with multiple functions.
• Provide medical leadership for operational strategy including site selection and enrollment.
• Perform medical monitoring, coding, and data cleaning with Clinical Operations.
• Author/regulatory submissions and represent the company at regulatory meetings.
• Prepare safety charters and management plans; coordinate SAB/DMC meetings.
• Maintain scientific expertise by literature review and attending meetings; advise leadership.

Skills

Clinical development leadership

Neurology background

Regulatory compliance

Medical monitoring

Team management

Gene therapy experience

Education

MD/DO or foreign equivalent

Neurology residency

Job description

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.