Director, Early Clinical Development – CNS

🕒 October 21

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👔 Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

• 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

• 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

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