Note: The job is a remote job and is open to candidates in USA. Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking an Executive Director, Clinical Development – Neurology to lead clinical programs and supervise the clinical development team, focusing on expanding the neurology pipeline and ensuring the integrity of clinical studies.
Responsibilities
- Serve as the therapeutic area lead of the Neurology Gene therapy clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics
- Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies
- 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 (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings
- Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team
- Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc
- 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
- Be an active participant with the gene therapy leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted
Skills
- You must have an 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 in addition to the above education 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, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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
Company Overview
Company H1B Sponsorship