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
Job title
Executive Director, Clinical Development – Neurology
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