Otsuka Pharmaceutical Companies (U.S.) · 11 hours ago
Director, Early Clinical Development - CNS
United States
Full-time
Remote
Lead/Staff, Director/Executive
$186K/yr - $279K/yr
5+ years expOtsuka Pharmaceutical Companies (U.S.) is focused on advancing healthcare through innovation, and they are seeking a Director to lead Early Clinical Development activities. This role involves strategic leadership in early clinical development for CNS-related projects, ensuring integration across various functions and driving decision-making based on clinical data.
Health CareMedical
Responsibilities
Serve as scientific and clinical expert in CNS translational medicine and early clinical development, contributing to strategic program decisions; serve as ECD lead on development teams for multiple assets
Drive Research-to-Development (R2D) strategies and stage-gate decision-making, including indication prioritization and go/no-go based on mechanistic rationale, benefit-risk, and clinical unmet need as well as on 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 as well as new formulation technologies
Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds. Engage with external experts and key opinion leaders to inform translational and Proof of Concept (PoC) strategy and maintain scientific leadership
Represent ECD in cross functional as well as internal/external collaborations (BD, etc.) on activities related to early phase target and asset identification. Support regulatory interactions (e.g., pre-IND, 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 or public-private partnerships operating in pre-competitive settings to advance internal clinical development capabilities
Interact with other disciplines within the EDO to promote, initiate and elevate cross-functional early development activities. 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
Qualification
Required
MD, MD/PhD, or PhD with subspecialty training in neurology or psychiatry/clinical psychology
5+ years of translational medicine and/ early clinical development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC
Expert understanding of industry best practices and adjacent functional areas
Demonstrated ability to coordinate and guide cross-functional teams in matrixed, global setting, with solid strategic thinking and the ability to make informed decisions amid uncertainty
Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders
Preferred
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
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life
Accidental death & dismemberment
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
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