Director, Early Clinical Development - CNS

Director, Early Clinical Development - CNS at Otsuka America Pharmaceutical Inc. in Boise, Idaho, United States Job Description The Director will lead activities related to Early Clinical Development (ECD) essential to the growth of Otsuka’s discovery and early phase pipeline within OPDC’s Early Development Organization (EDO). Reporting to the ECD CNS Therapeutic Area Head, this Director is a strategic scientific and clinical leader accountable for the end-to-end early clinical development strategy and execution for Otsuka’s early phase portfolio, with emphasis on CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation. The role shapes program strategy from indication selection through early clinical development (pre-IND through first-in-human and clinical proof of concept) and go/go no decisions based on clinical and/or biomarker driven endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. The Director, ECD - CNS, in alignment with the ECD therapeutic area head and functional head VP, collaborates with EDO senior leaders to identify, introduce, and implement translational tools or studies for discovery and early phase programs and establish strategic plans and objectives. Key Responsibilities + Serve as scientific and clinical expert in CNS translational medicine and early clinical development, contributing to strategic program decisions; serve as ECD lead on development teams for multiple assets. + Drive Research-to-Development (R2D) strategies and stage-gate decision-making, including indication prioritization and go/no-go based on mechanistic rationale, benefit-risk, and clinical unmet need as well as on clinical and/or biomarker driven endpoints. Prepare and present decision-quality data packages for internal governance reviews to support stage-gate decisions. + Interact with internal and external groups to evaluate new compounds, molecular and biological targets as well as new formulation technologies. + Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds. Engage with external experts and key opinion leaders to inform translational and Proof of Concept (PoC) strategy and maintain scientific leadership. + Represent ECD in cross functional as well as internal/external collaborations (BD, etc.) on activities related to early phase target and asset identification. Support regulatory interactions (e.g., pre-IND, IND submissions) and ensure translational strategies align with regulato To view full details and how to apply, please login or create a Job Seeker account

Created: 2026-02-12