Executive Director, Clinical Development - Neurology

Role Summary

Executive Director, Clinical Development – Neurology to lead clinical programs across different diseases and supervise the clinical development team. The role includes medical monitoring and oversight of assigned clinical programs, monitoring of clinical studies, review and interpretation of clinical trial data, authoring clinical study and regulatory communications, and monitoring of competitor activities and data. The position will help formulate the neurology pipeline and portfolio expansion, working closely with the research and commercial departments. This role reports to the VP, Clinical Development - Gene Therapy. The position may be remote with occasional travel; candidates should be able to work effectively from anywhere while staying connected to the team, with in-person collaboration as needed, including options to work remotely most of the time if near Bridgewater, NJ or San Diego, CA facilities.

Responsibilities

• Serve as the therapeutic area lead of the Neurology Gene therapy clinical development team, partnering with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
• Provide medical leadership for key areas of clinical operational strategy, including site selection, enrollment, feasibility, and serve as primary escalation point for issues impacting quality and integrity of clinical studies.
• Perform medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
• Ensure the medical integrity of clinical study reports and data interpretation/communication.
• Author or oversee authorship of 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, or other specific management plans and manuals in a cross-functional team.
• Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
• Organize scientific advisory board meetings and data safety monitoring committee meetings.
• Maintain a high level of clinical and scientific expertise in Neurologic disease areas by reviewing the literature and attending medical/scientific meetings.
• Be an active participant with the gene therapy leadership team on strategic direction and provide guidance on opportunities and hurdles forecasted.

Qualifications

• Required: MD, DO, or foreign equivalent with 10+ years of global experience in neurology clinical development within the pharmaceutical/biotech industry.
• Required: Experience across multiple phases of clinical research (Phases 1-3).
• Required: 5+ years of management experience within clinical development.
• Required: Prior Gene Therapy experience.
• Required: Clinical residency training in neurology.
• Required: Knowledge of ICH-GCP and FDA regulatory guidelines.
• Preferred: A PhD in addition to the above education is strongly preferred.
• Preferred: Pediatric experience.
• Preferred: Prior experience with drug approvals in the gene therapy space.

Skills

• Medical leadership and strategic clinical development
• Regulatory submissions and interactions with regulatory authorities
• Clinical operations collaboration, site feasibility, and enrollment planning
• Data interpretation, safety monitoring, and clinical data quality
• Effective communication with cross-functional teams and external stakeholders

Education

• Clinical residency training in neurology (required)

Additional Requirements

• Location/Work Arrangement: Fully remote possible; occasional travel; option to work remotely most of the time if near Bridgewater, NJ or San Diego, CA facilities with in-person collaboration as needed.
• Travel Requirements: Occasional domestic or international travel (approximately 20%).