Senior Director, Toxicology (CNS Specialist)

Key Responsibilities Define and execute nonclinical safety strategies for assigned small molecule CNS programs across discovery, IND-enabling, and clinical development stages. Develop safety strategies for new CNS targets, lead optimization programs, and platform technologies. Identify gaps/emerging risks and implement risk mitigation plans (engage external experts as appropriate). Stay current on scientific literature and regulatory guidance for CNS toxicology. Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies (CNS-relevant endpoints/models). Lead outsourcing for design, monitoring, execution, and reporting of nonclinical toxicology studies; ensure quality, compliance, and timely delivery. Manage/monitor CRO studies; review and edit study reports and coordinate finalization. Integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform decisions. Author/critically review toxicology sections of pre-IND/IND/CTA/IB/DSUR/NDA documents; prepare written responses to health authorities. Collaborate cross-functionally (biology, DMPK, pathology, pharmacology, clinical, regulatory, CMC); provide mentorship to entry-level toxicology staff. Qualifications PhD (Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related); board certification (e.g., DABT, ERT). 13+ years pharma/biotech R&D in nonclinical and regulatory toxicology. Substantial CNS/neuroscience drug development experience. Expertise across discovery, IND-enabling, and early clinical development for CNS-active small molecules. Experience as toxicology lead on cross-functional programs. Extensive experience with global regulatory submissions and health authority responses. Working knowledge of FDA/EMA/ICH guidance and GLP; understanding of QA/regulatory/clinical interfaces. Proven success leading outsourced studies and managing CRO study directors. Strong ability to integrate datasets; work independently; excellent scientific writing and communication. Travel up to 25%–30%. Compensation/Benefits Annual base salary range: $260,000–$295,000; discretionary annual bonus. 401(k), company-sponsored medical/dental/vision/life insurance, paid time off, health and wellness program. #J-18808-Ljbffr Scorpion Therapeutics