Contractor involved in project delivery phases at Datacom, providing expertise in software development, QA, or IT infrastructure. Collaborating with cross - functional teams for high - quality solutions.
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
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