Executive Director, Clinical Development - Neurology

About the role

We're seeking an Executive Director, Clinical Development – Neurology to join our team. Reporting to the VP, Clinical Development - Gene Therapy, this role involves leading clinical programs across various neurological diseases and supervising the clinical development team. Key responsibilities include designing and implementing clinical development strategies, overseeing clinical protocols, and ensuring the medical integrity of clinical studies.

Responsibilities

• Serve as the therapeutic area lead of the Neurology Gene therapy clinical development team, collaborating with clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
• Provide medical leadership for operational strategy, including site selection, enrollment, and feasibility, and act as the primary point of escalation for clinical study issues.
• Perform medical monitoring, coding, and data cleaning, and ensure the medical integrity of clinical study reports and data interpretations.
• Author or oversee the authorship of clinical sections of regulatory submissions and represent the company at regulatory meetings, including Advisory Committee Meetings.
• Prepare safety charters, DMC charters, or other specific management plans and manuals, and organize scientific advisory board and data safety monitoring committee meetings.
• Maintain a high level of clinical and scientific expertise in the Neurologic disease area by reviewing the literature and attending medical/scientific meetings.
• Participate in the gene therapy leadership team on strategic direction and provide guidance on opportunities and hurdles.

Requirements

• An MD, DO, or foreign equivalent with 10+ years of global neurology clinical development experience.
• Experience across multiple phases of clinical research (Phases 1-3).
• 5+ years of management experience within clinical development.
• Prior experience in gene therapy.
• Clinical residency training in neurology.
• Knowledge of ICH-GCP and FDA regulatory guidelines.

Qualifications

• A PhD is strongly preferred.
• Pediatric experience is highly valued.
• Prior experience with drug approvals in the gene therapy space is advantageous.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and a variety of other benefits including paid time off, fertility and family-forming benefits, caregiver support, flexible work schedules, and more. We also provide a generous 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.

Pay

$306,000.00 - $417,000.00 Annual