CNS Early Clinical Development Director

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) match

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Early Clinical Development (ECD) focusing on CNS programs. You will shape strategy from target ID through IND/PoC, directing translational studies, biomarker strategies, and regulatory readiness while aligning with discovery, nonclinical, and commercial teams.

You will lead cross-functional teams, collaborate with external experts, and ensure safety monitoring and governance across assets in the CNS space.

Qualifications

• MD/PhD with subspecialty training in Clinical psychology/neuropsychology.
• 5+ years translational medicine or early clinical development experience with biologics or small molecules.
• Ability to coordinate cross-functional teams in a global setting and influence stakeholders.
• Outstanding communication skills with the ability to synthesize complex data.

Responsibilities

• Serve as CNS translational medicine and early clinical development expert on strategy and development teams.
• Drive R2D strategies and stage-gate decisions based on mechanistic rationale and endpoints.
• Interact with internal/external groups to evaluate new compounds and targets.
• Collaborate with external experts and KOLs to inform PoC strategy.
• Support regulatory interactions (pre-IND/IND) and ensure alignment with regulatory requirements.
• Lead development efforts from target ID through IND and PoC, including protocols and safety oversight.

Skills

MD/PhD or equivalent

Translational medicine

Early clinical development

Cross-functional leadership

IND/FIH/PoC experience

Biomarkers

Regulatory collaboration

Communication skills

Decision making under uncertainty

Education

MD/PhD or PhD with clinical psychology/neuropsychology subspecialty

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Early Clinical Development (ECD) focusing on CNS programs. You will shape strategy from target ID through IND/PoC, directing translational studies, biomarker strategies, and regulatory readiness while aligning with discovery, nonclinical, and commercial teams.

You will lead cross-functional teams, collaborate with external experts, and ensure safety monitoring and governance across assets in the CNS space.