Director, Early Clinical Development – CNS

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee activities associated with Early Clinical Development to support Otsuka’s discovery and early-phase pipeline.

• Take ownership of the comprehensive early clinical development strategy and implementation for the early-phase portfolio, focusing on CNS.

• Formulate program strategy from indication selection through pre-IND, first-in-human trials, proof of concept, and go/no-go decisions.

• Collaborate across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions.

• Act as a scientific and clinical authority in CNS translational medicine and early clinical development.

• Lead ECD initiatives on development teams for various assets.

• Propel Research-to-Development strategies and facilitate stage-gate decision-making.

• Prepare and deliver decision-quality data packages for internal governance evaluations.

• Assess new compounds, molecular and biological targets, and formulation technologies.

• Partner with research organizations to promote the advancement of early- and discovery-phase compounds.

• Engage with external experts and key opinion leaders to guide translational and proof-of-concept strategies.

• Represent ECD in cross-functional and internal/external collaborations, including business development efforts.

• Assist with regulatory interactions, including pre-IND and IND submissions.

• Lead development initiatives from target identification through IND and proof of concept.

• Provide medical leadership for early-phase clinical protocols, informed consent documents, and investigator brochures.

• Monitor safety and contribute to DSMB or safety review activities.

• Support or lead public-private partnerships in pre-competitive environments.

• Advocate for and enhance cross-functional early development activities within the EDO.

• Collaborate with biomarker and digital innovation teams on biomarker-driven CNS strategies.

• Assist team members in developing expertise in translational and early clinical development.

⛳️ Requirements

• MD, MD/PhD, or PhD with specialized training in Clinical psychology/neuropsychology.

• 5+ years of experience in translational medicine and/or early clinical development.

• Proven track record of advancing biologics and/or small molecules through IND and FIH/PoC stages.

• In-depth understanding of industry best practices and related functional areas.

• Capability to coordinate and lead cross-functional teams in a matrixed, global environment.

• Strong strategic thinking skills and the ability to make informed decisions in uncertain conditions.

• Excellent communication skills.

• Ability to synthesize complex data and influence executive stakeholders.

• Preferred: MD with specialty training in psychiatry and/or neurology.

• Preferred: Extensive expertise in CNS, particularly in psychiatry, neurodegenerative diseases, and/or neuroinflammation.

• Preferred: Experience in executing clinical study plans to facilitate decision-making.

• Preferred: Background with external collaborations.

• Willingness to travel up to 20%.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Incentive opportunities.