Director, Early Clinical Development – CNS
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Posted: 10/21/2026Director, Early Clinical Development – CNS
Otsuka Pharmaceutical Companies (U.S.)Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in early clinical development and translational medicine, particularly in CNS, with a strong ability to lead cross-functional teams and drive strategic decision-making from target identification through IND and proof of concept.
Highest-signal resume keywords
Early Clinical Development StrategyTranslational Medicine ExpertiseCNS Program LeadershipIND Submission ExperienceCross-Functional Team Coordination
About the role
Key responsibilities & impact- Lead activities related to Early Clinical Development supporting Otsuka’s discovery and early-phase pipeline
- Own end-to-end early clinical development strategy and execution for the early-phase portfolio, with emphasis on CNS
- Shape program strategy from indication selection through pre-IND, first-in-human, proof of concept, and go/no-go decisions
- Integrate discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions
- Serve as scientific and clinical expert in CNS translational medicine and early clinical development
- Serve as ECD lead on development teams for multiple assets
- Drive Research-to-Development strategies and stage-gate decision-making
- Prepare and present decision-quality data packages for internal governance reviews
- Evaluate new compounds, molecular and biological targets, and formulation technologies
- Partner with research organizations to advance early- and discovery-phase compounds
- Engage external experts and key opinion leaders to inform translational and proof-of-concept strategy
- Represent ECD in cross-functional and internal/external collaborations, including business development
- Support regulatory interactions, including pre-IND and IND submissions
- Lead development efforts 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
- Support or lead public-private partnerships in pre-competitive settings
- Promote and elevate cross-functional early development activities within the EDO
- Collaborate with biomarker and digital innovation teams on biomarker-driven CNS approaches
- Support team members in building translational and early clinical development expertise
Requirements
What you’ll need- MD, MD/PhD, or PhD with subspecialty training in Clinical psychology/neuropsychology
- 5+ years of translational medicine and/or early clinical development experience
- Track record of advancing biologics and/or small molecules through IND and FIH/PoC
- Expert understanding of industry best practices and adjacent functional areas
- Ability to coordinate and guide cross-functional teams in a matrixed, global setting
- Solid strategic thinking and ability to make informed decisions amid uncertainty
- Outstanding communication skills
- Ability to synthesize complex data and influence executive stakeholders
- Preferred: MD with specialty training in psychiatry and/or neurology
- Preferred: Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and/or neuroinflammation
- Preferred: Experience implementing clinical study plans to drive decision-making
- Preferred: Experience with external collaborations
- Ability to travel 20%
Benefits
Comp & perks- Comprehensive medical, dental, vision, and prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- Generous 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Other company-provided benefits
- Incentive opportunity
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Protocol DevelopmentDecision-Quality Data PreparationBiologics AdvancementSmall Molecule DevelopmentSafety MonitoringClinical Study Plan ImplementationData SynthesisRegulatory InteractionTarget IdentificationProof of Concept Execution
Soft Skills
Outstanding Communication SkillsStrategic ThinkingInfluencing Executive Stakeholders
Certifications & Qualifications
MDMD/PhDPhD
Industry Keywords
CNSNeuropsychologyPsychiatryNeurodegenerative DiseaseNeuroinflammationResearch-to-Development StrategiesPublic-Private PartnershipsCross-Functional CollaborationMatrixed Global SettingExternal Collaborations