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.

• 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%.

• 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.