Executive Director, Clinical Development – Neurology
Insmed Incorporated
full-time
Posted on:
Location Type: Hybrid
Location: California, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $306,000 - $417,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development strategyclinical protocolsmedical monitoringcodingdata cleaningregulatory submissionsclinical researchgene therapydata interpretationclinical study reports
Soft skills
medical leadershipcollaborationcommunicationorganizational skillsteam leadership
Certifications
MDDOPhD