Associate Director, Clinical Development - Neurology

Role: Associate Director, Clinical Development – Neurology, providing clinical leadership and scientific expertise for neurology-focused drug development projects, including rare neurological and pediatric neurogenetic disorders. Responsibilities: lead key Phase 3 trials by developing investigator relationships, ensuring high-quality study execution, reviewing data, managing risks, and contributing to regulatory documents such as protocols, INDs, and CSRs. Engage stakeholders including KOLs and regulators to inform development strategies; analyze clinical data; support publication efforts; and stay current with scientific literature. Qualifications: PhD, MD, or PharmD with 5+ years’ experience in clinical development, ideally in neurology, rare diseases, or pediatrics; strong cross-functional collaboration skills; experience with protocol and regulatory document writing; and familiarity with data review tools. Preferred: experience supporting NDA filings and managing vendors or DSMBs, and supporting FDA inspections. High-Value: neurology (including neurodegeneration, neuromuscular, and pediatric neurogenetic disorders), Phase 3, regulatory submissions, and cross-disciplinary collaboration. Work setup: fully onsite, remote, or hybrid with quarterly travel to Carlsbad; no specified travel beyond that.