Associate Director, Study Operation Manager - Nonclinical Toxicology

Role: Associate Director, Study Operations - Nonclinical Toxicology, overseeing external CROs conducting toxicology and safety pharmacology studies for Orexin receptor agonist programs. Responsibilities: manage study forecasting, budgeting, planning, data flow, quality assurance, compliance, and cross-functional collaboration; review study protocols and reports; coordinate compound shipments; monitor study progress; maintain project timelines and deliverables; facilitate communication with senior management. Requirements: BSc/MSc in toxicology, pharmacology, or related field; minimum 6 years in biotech/pharma nonclinical toxicology or safety pharmacology; strong scientific knowledge; excellent organizational and communication skills; proficiency in data management software. Preferred: experience supporting CNS, sleep-wake, or neurodegenerative therapeutic areas; contribution to IND/CTA submissions; familiarity with FDA, EMA, ICH regulations; experience in fast-paced biotech environments. HighValue: neuro/neurology focus, sleep-wake disorder indications, nonclinical studies in toxicology and safety pharmacology, CRO oversight, remote work with occasional travel.