About the Role:
We're looking for an Executive Director, Clinical Development - Neurology to help us expand what's possible for patients with serious diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and supervise the clinical development team.

This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. This individual will play a crucial role in formulating the company's neurology pipeline and portfolio expansion, working closely with the research and commercial departments.

What You'll Do:

In this role, you'll have the opportunity to design and implement the clinical development strategy and clinical protocols while delivering high quality clinical programs, from first-in-human trials, through to full development. You'll also:

• 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.

Who You Are:

You must have an MD, DO, or foreign equivalent along with 10+ years of global experience in neurology clinical development within the pharmaceutical/biotech industry. Additionally, you have:

• 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.

Nice to have (but not required):

• 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.

Where You'll Work

This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Alternatively, if you live within a drivable distance of our Bridgewater, NJ or San Diego, CA facilities, you'll have the option to work remotely most of the time, but with more in-person collaboration when it matters most.

Travel Requirements

This role requires occasional domestic or international travel (approximately 20%).

#LI-MM1
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Pay Range:
$306,000.00-417,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.