Director, Early Clinical Development - CNS

Otsuka Pharmaceutical Co., Ltd.

3d•$186,489 - $278,875

About The Position

The Director will lead Early Clinical Development (ECD) activities supporting 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 strategic scientific and clinical leader is 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 pre-IND, first-in-human, and clinical proof of concept, and supports go/no-go decisions using clinical and/or biomarker-driven endpoints. It ensures integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. In alignment with the ECD therapeutic area head and functional head VP, the Director collaborates with EDO senior leaders to identify, introduce, and implement translational tools or studies for early-phase programs and establish strategic plans and objectives.

Requirements

MD, MD/PhD, or PhD with subspecialty training in clinical psychology or neuropsychology.
At least 5 years of translational medicine and/or early clinical development experience, with a track record of advancing biologics and/or small molecules through IND and first-in-human/proof-of-concept.
Expert understanding of industry best practices and adjacent functional areas.
Demonstrated ability to coordinate and guide cross-functional teams in a matrixed, global setting.
Strong strategic thinking and ability to make informed decisions amid uncertainty.
Outstanding communication skills, including the ability to synthesize complex data and influence executive stakeholders.

Nice To Haves

MD with specialty training in psychiatry and/or neurology.
Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and/or neuroinflammation.
Experience implementing clinical study plans to drive decision-making.
Experience with external collaborations.

Responsibilities

Serve as a scientific and clinical expert in CNS translational medicine and early clinical development, contribute to strategic program decisions, and serve as ECD lead on development teams for multiple assets.
Drive Research-to-Development strategies and stage-gate decision-making, including indication prioritization and go/no-go decisions informed by mechanistic rationale, benefit-risk, clinical unmet need, and 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, and formulation technologies.
Partner with internal and external research organizations to facilitate development of early-phase and discovery-phase compounds.
Engage external experts and key opinion leaders to inform translational and proof-of-concept strategy and maintain scientific leadership.
Represent ECD in cross-functional and internal or external collaborations, including business development activities, related to early-phase target and asset identification.
Support regulatory interactions, such as pre-IND meetings and IND submissions, and ensure translational strategies align with regulatory requirements.
Lead scientific and clinical development efforts for assigned programs from target identification through IND and proof of concept.
Provide medical leadership for early-phase clinical protocols, informed consent forms, and investigator brochures; monitor safety and contribute to DSMB or safety review activities as needed.
Support or lead public-private partnerships in pre-competitive settings to advance internal clinical development capabilities.
Promote, initiate, and elevate cross-functional early development activities with other EDO disciplines.
Collaborate with biomarker and digital innovation teams to develop and implement biomarker-driven approaches for CNS programs.
Support the development of team members to build translational and early clinical development expertise.