Director, Nonclinical DMPK: Strategy & Leadership

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); On-site; USD 186,000 - 279,000; Full time

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks a Director of Nonclinical DMPK to lead strategic DMPK programs for small molecules. The role guides cross‑functional teams, shapes regulatory submissions, and sets scientific standards across discovery and development activities.

You will oversee IND/NDA enabling studies, manage timelines and budgets, and act as a DMPK expert informing senior leadership on program progression and risk mitigation.

Qualifications

• MSc or PhD in Chemistry, Biology, Pharmaceutical Sciences, or related area with at least 7 years in pharma or CRO.
• Proven track record delivering discovery/early development assets to clinic and POC.
• Strong technical experience in planning and executing nonclinical studies.
• Thorough knowledge of regulatory requirements and the drug development process.
• Regulatory expertise preferred, including IND/CTA submissions.
• Ability to manage multiple programs and shifting business needs.
• Detail-oriented with strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Serve as the DMPK functional expert on cross-functional teams and provide strategic nonclinical safety recommendations.
• Communicate DMPK findings and risk assessments to project teams and senior leadership.
• Provide strategic oversight of DMPK activities across multiple programs and IND/NDA enabling studies.
• Influence portfolio decisions through integrated interpretation of DMPK data and risk assessments.
• Review, analyze and interpret scientific data and integrate findings into nonclinical strategies.
• Manage outsourcing, timelines, budgets, and deliverables for assigned programs.
• Author/co-author and review regulatory documents.
• Collaborate to incorporate new guidance requirements.
• Analyze competitive scientific knowledge from external sources.
• Establish scientific standards and best practices across Nonclinical DMPK.
• Contribute to continuous improvement initiatives and evolving regulatory guidance.

Skills

DMPK leadership

Cross-functional collaboration

Regulatory experience

Data interpretation

Communication skills

Education

MSc/PhD in Chemistry, Biology, or Pharmaceutical Sciences

Job description

Otsuka Pharmaceutical Companies (U.S.) seeks a Director of Nonclinical DMPK to lead strategic DMPK programs for small molecules. The role guides cross‑functional teams, shapes regulatory submissions, and sets scientific standards across discovery and development activities.

You will oversee IND/NDA enabling studies, manage timelines and budgets, and act as a DMPK expert informing senior leadership on program progression and risk mitigation.