Director/Senior Director, Preclinical Program Leadership

Role: Lead preclinical program operations from candidate nomination through IND clearance for biologics, including protein therapeutics, in an AI-driven biotech setting. Responsibilities: manage cross-functional workflows, timelines, budgets, and dependencies; oversee external CRO/CDMO collaborations; develop and maintain integrated development plans; design and review study protocols; and establish scalable operational processes. Requirements: advanced degree in biochemistry, pharmacology, toxicology, or related field; 8+ years (Ph.D.) or 12+ years (Master's) industry experience; proven success managing multiple IND programs with CRO/CDMO vendors; deep understanding of drug development, GxP, ICH, and FDA preclinical guidelines; strong stakeholder influence skills. Preferred: experience in biologics and protein therapeutics; strategic and operational judgment; excellent communication and organizational skills; comfort in fast-paced, evolving environments. High-Value: biologics, protein therapeutics, IND enabling, CRO/CDMO management, GxP, ICH, FDA preclinical requirements. WorkSetup: remote.