Insmed Incorporated · 2 days ago
Executive Director, Clinical Development - Neurology
Headquarters, NJ
Full-time
Hybrid
Director/Executive
$306K/yr - $417K/yr
10+ years expInsmed 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, supervise the clinical development team, and play a crucial role in formulating the company’s neurology pipeline and portfolio expansion.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Preferred
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
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-09
2026-01-09
Company data provided by crunchbase