Executive Medical Director, Neurology, Clinical Development

Responsibilities

• Designing and implementing the clinical development strategy and clinical protocols and delivering high-quality clinical programs, from first-in-human trials through to full development.
• Serve as the therapeutic area lead of the Neurology Gene Therapy Clinical Development team, partnering closely with heads of Clinical Operations, Toxicology, Regulatory Affairs, Commercial, Pharmacovigilance, Clinical Quality, and Biostatistics.
• Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as the primary point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
• 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 presentations at Advisory Committee Meetings.
• Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.
• Support or prepare data interpretation and clinical trial reports.
• Prepare Investigator Alert letters and SAE reports in collaboration with Clinical Operations as required.
• Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
• Analyze, interpret, and organize data for presentations and publications.
• Interact with external experts to gather input.
• Organize scientific advisory board meetings and Data Safety Monitoring Committee meetings.
• Maintain a high level of clinical and scientific expertise in the neurologic disease area(s) by reviewing the literature and attending medical/scientific meetings.
• Develop and manage budgets required to implement clinical development plans and regularly report plan progress to stakeholders.
• Be an active participant with the Gene Therapy leadership team on the strategic direction of the business and provide guidance on opportunities and hurdles that may be forecasted.
• Support business development, potential product evaluation, and due diligence.
• Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, Data Safety Monitoring Boards, patients, advocacy groups, etc.) customers.
• Coach, manage, and mentor direct reports while providing job enrichment and developmental opportunities.

Requirements

• 5+ years of management experience in Neurology Clinical Development.
• Pediatric experience preferred.
• Gene Therapy experience preferred.
• Clinical residency training in Neurology.
• Education - Required: MD, or foreign equivalent, with clinical experience.
• PREFERRED: PhD in addition to the above.
• 10+ years of global experience in clinical development in the pharmaceutical/biotech industry across multiple phases of clinical research (Phase 13).
• Knowledge of ICH-GCP and FDA regulatory guidelines.
• Travel - Domestic and/or international travel required (20%).