Senior Director, Translational Medicine, CNS – Early Development

Job Summary

The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early Clinical Development within OPDC’s Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational Medicine Experts reporting to her/him on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and clinical leader accountable for the end-to-end translational 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. As an industry-leading expert and trusted advisor to senior leadership, this leader directs complex, cross-functional initiatives with enterprise impact, and helps define the operating model and culture of the EDO.

• Serve as subject matter expert and thought leader in areas of strategic importance to Otsuka; act as a trusted advisor to senior leadership on early development strategy in the CNS space.
• Lead CNS TM team on complex, business-critical programs with enterprise impact; shape portfolio strategy and influence resource allocation for Otsuka's early phase 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.
• Serve as a functional cultural ambassador, modeling EDO Ways of Working and 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, integrating pharmacokinetics, pharmacodynamics, safety, and biomarker strategies.
• Collaborate with digital, diagnostics and biomarker groups to support the development of biomarkers throughout the life cycle of Otsuka's compounds.
• Oversee the design and execution of FIH through PoC studies; ensure robust translational hypotheses, dose selection, and decision-quality data packages.
• Ensure nonclinical, toxicology and DMPK strategies are aligned with intended clinical development plans.
• Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in safety review/DSMB activities in EDO as needed.
• Ensure CNS TM team robustly represents line function via collaboration with other line functions including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance.
• Support and guide team through all Scientific Review Board and Endorsement Board interactions, as part of the EDO.

• Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations, Regulatory, and Biostatistics; drive alignment and accountability to milestones.
• Anticipate and solve multi-dimensional complex problems, balancing scientific rigor, operational feasibility, and business impact.
• Present strategy, risk/mitigation, and recommendations to governance and executive committees; influence enterprise decision-making.

• Lead scientific and medical due diligence for external opportunities (academic collaborations, in-licensing candidates, platforms); benchmark against competitive landscape and standards of care.
• Build and maintain strong KOL, investigator, and partner relationships; represent Otsuka and OPDC at scientific, clinical, and regulatory interactions.
• Drive innovation of CNS biomarkers in collaboration with biomarker and digital innovations teams and serve as subject matter expert related to relevance of CNS biomarkers for go/no-go decisions.

• Build, lead, and develop a high-performing director-level Translational Medicine team (MDs, PhDs, and MD, PhDs, including Directors/Senior Directors); drive succession planning and talent.>
• Support the Head of Translational Medicine in departmental planning, including staffing, budgeting, and expense priorities pertaining to the CNS portfolio.

• Ensure adherence to GCP, ICH, and applicable regulations; drive…