Director, Early Clinical Development – CNS

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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