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 for Neurology Gene therapy clinical development, collaborating with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.
• Provide medical leadership for clinical operational strategy, focusing on site selection, enrollment, feasibility, and addressing issues that may impact the quality and integrity of clinical studies.
• Perform medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
• Audit and interpret clinical study reports and communicate data interpretations.
• Author or oversee the authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.), representing the company at regulatory meetings, including presenting at Advisory Committee Meetings.
• Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.
• 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.
• Participate in the gene therapy leadership team on strategic directions and provide guidance on opportunities and challenges.

Requirements

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

Qualifications

• A PhD is strongly preferred.
• Pediatric experience is a huge plus.
• 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 wellness benefits. We also provide generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. Additionally, we offer a 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), as well as company-paid life and disability insurance.

Pay

$306,000.00 - $417,000.00 Annual