Senior Director, Translational Medicine, CNS – Early Development
About the role
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.
Responsibilities
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.
Shape 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.
Ensure seamless integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions.
Model EDO Ways of Working and foster 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.
Robustly represent 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 development.
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 inspection/readiness standards across programs.
Proactively identify and manage program and portfolio risks with clear mitigation and contingency plans.
Qualifications
MD, PhD, or MD/PhD with subspecialty training in neurology or psychiatry strongly preferred.
10–15+ years of translational and/or medical/clinical/development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC.
Recognized thought leader with scientific contributions (publications, presentations); expert understanding of industry best practices and adjacent functional areas.
Proven success leading complex, cross-functional teams in a matrixed, global environment; exceptional strategic thinking and decision-making under uncertainty.
Demonstrated experience in early development and Health Authority interactions (e.g., pre-IND, IND, End-of-Phase 2).
Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders.
Preferred
Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation.
Experience implementing clinical study plans to drive decision-making.
Experience with external collaborations, including collaborative animal model experiments, key opinion leader interactions and advisory boards.
Prior experience building or scaling early development operating models and ways of working.
Compensation
$225,490.00 - $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.