Director of Early Clinical Development - CNS

The Director of Early Clinical Development will spearhead key initiatives pivotal to the advancement of Otsuka's early-phase pipeline in the CNS therapeutic area. As a distinguished scientific and clinical leader reporting to the ECD CNS Therapeutic Area Head, you will oversee comprehensive early clinical development strategies, focusing on psychiatry, neurodegenerative diseases, and neuroinflammation. This strategic role encompasses every facet of early development, from indication selection and pre-IND to first-in-human trials and clinical proof of concept. You will leverage clinical insights and biomarker-driven endpoints to guide decisions and ensure integration across various functions, including discovery, nonclinical, clinical pharmacology, regulatory, and commercial teams. Key Responsibilities Serve as a scientific and clinical authority in CNS translational medicine and early clinical development, playing a lead role for multiple asset development teams. Develop Research-to-Development (R2D) strategies and guide stage-gate decision-making that includes prioritizing indications and making informed go/no-go decisions based on mechanistic insights, benefit-risk analysis, clinical needs, and clinical endpoints. Engage with internal teams and external partners to assess new compounds, molecular targets, and innovative formulation technologies. Collaborate with research organizations to drive the development of early-phase compounds. Interact with external experts and KOLs to shape translational and proof-of-concept strategies. Represent early clinical development in cross-functional and external collaborations, ensuring alignment of translational strategies with regulatory requirements. Lead scientific and clinical development efforts for assigned programs, including development of protocols, informed consent forms, and material for investigator brochures while monitoring safety and participating in safety review activities as necessary. Oversee public-private partnerships in pre-competitive settings to enhance internal clinical development capabilities. Foster collaboration across EDO disciplines to initiate and promote early development activities, working closely with biomarker and digital innovation teams to implement biomarker-driven strategies. Support the growth and expertise of team members in translational and early clinical development. Travel requirement is 20%. Qualifications Required MD, MD/PhD, or PhD with specialized training in neurology, psychiatry, or clinical psychology. Over 5 years of experience in translational medicine or early clinical development, successfully advancing biologics or small molecules through IND and first-in-human stages. In-depth knowledge of industry best practices and related functional areas. Proven ability to coordinate cross-functional teams in a global matrix environment, exhibiting strong strategic thinking and decision-making skills even in uncertain situations. Exceptional communication skills, capable of synthesizing complex data and influencing executive stakeholders effectively. Preferred MD with specialization in psychiatry or neurology. Extensive experience in CNS, particularly in psychiatry, neurodegenerative diseases, or neuroinflammation. History of implementing clinical study plans to inform decision-making. Experience with external collaborations. Competencies Accountability for Results: Remain focused on strategic objectives while holding yourself accountable for performance and driving change. Strategic Thinking & Problem Solving: Make decisions considering long-term impacts on patients, customers, and the organization. Patient & Customer Centricity: Maintain focus on the needs of customers and stakeholders. Impactful Communication: Communicate clearly and respectfully while influencing outcomes across all organizational levels. Respectful Collaboration: Value diverse perspectives and foster partnerships to achieve common goals. Empowered Development: Take initiative in professional growth as an essential business practice. Salary Range: $186,489.00 - $278,875.00, plus potential incentives. Salary varies based on individual experience, skills, and internal comparisons. Company Benefits: Otsuka offers comprehensive medical, dental, and vision coverage, life insurance, disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, and paid leave programs, among other benefits. Otsuka is an equal opportunity employer and welcomes qualified applicants without regard to race, gender, age, disability, or other legally protected characteristics. For accommodations related to the application process for individuals with disabilities, please contact the Otsuka accommodations request team. This job description is intended to outline the responsibilities and expectations of the role and may evolve as business needs change. Otsuka reserves the right to revise responsibilities as necessary.

Created: 2026-03-13