Executive Director, Clinical Regulatory - Rare Diseases

Role: Senior leader overseeing global regulatory strategy for Denali's rare disease and CNS biologics portfolio, guiding development from IND/CTA through product approval and lifecycle management. Responsibilities: develop and implement program-level regulatory strategies, serve as primary Health Authority interface, lead major interactions (FDA, EMA, PMDA), and manage a team of Regulatory Leads. Play a strategic role in navigating expedited pathways (Breakthrough, RMAT, orphan designations), and provide regulatory input across clinical, biomarker, pediatric, and development plans. Monitor global regulatory trends, incorporate emerging technologies like AI, and represent the organization externally. Qualifications: Bachelor's in life sciences required; advanced degree (PhD, PharmD, MD, MS) preferred. 15+ years biopharma regulatory experience, including 7+ years leading teams and interacting with US/EU regulators, with proven success in biologics and rare disease development, especially in CNS indications. Deep knowledge of global regulations and accelerated pathways, with strong leadership, strategic thinking, and communication skills. High-value: biologics, rare diseases, CNS, global regulatory strategy, FDA/EMA interactions, expedited pathways, AI tools, senior management experience. Work setup: travel required for external engagements.