Executive Director, Clinical Development - Neurology

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? 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. Pediat ... (truncated, view full listing at source)