Hybrid Executive Director, Clinical Development – Neurology

at Insmed Incorporated

• Job title: Executive Director, Clinical Development – Neurology
• Job type: Full Time
• Experience level: Lead
• Salary: $306,000 - $417,000 per year
• Degree requirement: Postgraduate Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, United States

About the role

• Executive Director leading clinical development strategy in Neurology at Insmed. Overseeing clinical programs and medical monitoring while driving pipeline expansion in rare diseases.

Responsibilities

• Design and implement the clinical development strategy and clinical protocols
• Deliver high quality clinical programs, from first-in-human trials to full development
• Serve as the therapeutic area lead of the Neurology Gene therapy clinical development team
• Partner closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics
• Provide medical leadership for clinical operational strategy
• 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
• Represent the company at regulatory meetings
• 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)

Requirements

• MD, DO, or foreign equivalent
• 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
• A PhD is strongly preferred
• Pediatric experience is a huge plus
• Prior experience with drug approvals in the gene therapy space is an advantage

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back