Senior Director, Translational Medicine, CNS – Early Development

Senior Director, Translational Medicine, CNS – Early Development

Otsuka Pharmaceutical Companies (U.S.) is seeking a senior director to lead the Translational Medicine CNS Therapeutic Area. The role will report to the VP, Translational Medicine and Early Clinical Development within the Early Development Organization. This strategic scientific and clinical leader will oversee the early phase CNS portfolio, managing programs from indication selection to early clinical development (pre‑IND to first‑in‑human), and integrating across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions.

The senior director will manage a small team of Translational Medicine experts and direct complex cross‑functional initiatives with enterprise impact.

As the Translational Medicine CNS Therapeutic Area Head, the senior director will shape program strategy from indication selection through early clinical development (pre‑IND through first‑in‑human and clinical proof‑of‑concept), make go/no‑go decisions based on clinical and biomarker endpoints, and lead end‑to‑end translational strategy for Otsuka's early phase portfolio, with emphasis on psychiatry, neurodegenerative disease, and neuroinflammation. The role involves collaboration with discovery, nonclinical, clinical pharmacology, regulatory, and commercial teams, and serves as a trusted advisor to senior leadership.

• Serve as subject matter expert and trusted advisor on early development strategy in the CNS space.
• Lead CNS TM team on complex, business‑critical programs and shape portfolio strategy.
• Drive Research‑to‑Development (R2D) strategies and stage‑gate decision‑making.
• Serve as a functional cultural ambassador, fostering a high‑performance, inclusive, and learning‑oriented environment.

• Provide end‑to‑end translational leadership from indication selection through pre‑IND, FIH, and clinical PoC.
• Collaborate with digital, diagnostics, and biomarker groups to support biomarker development.
• Oversee the design and execution of FIH through PoC studies.
• Ensure nonclinical, toxicology and DMPK strategies align with intended clinical plans.
• Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in DSMB activities.
• Ensure robust collaboration with other line functions including Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development, Data & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance.
• Support and guide team through Scientific Review Board and Endorsement Board interactions.

• Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations, Regulatory, and Biostatistics.
• Anticipate and solve complex problems, balancing scientific rigor, operational feasibility, and business impact.
• Present strategy, risk/mitigation, and recommendations to governance and executive committees.

• Lead scientific and medical due diligence for external opportunities.
• Build and maintain KOL, investigator, and partner relationships; represent Otsuka at scientific, clinical, and regulatory interactions.
• Drive innovation of CNS biomarkers in collaboration with biomarker and digital innovation teams.

• Build, lead, and develop a high‑performing director‑level Translational Medicine team.
• Support the Head of Translational Medicine in departmental planning, staffing, budgeting, and expense priorities for the CNS portfolio.

• Ensure adherence to GCP, ICH, and applicable regulations; drive inspection/readiness standards across programs.
• Proactively identify and manage program and portfolio risks with clear mitigation and contingency plans.

• MD, PhD, or MD/PhD with subspecialty training in neurology or psychiatry strongly…