Senior Director, Clinical Pharmacology: PK/PD & MIDD

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 231,000 - 345,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a leadership role in Quantitative Pharmacology within the QTR department to oversee clinical pharmacology activities and mentor junior scientists across all stages of development.

The role includes leading PK/PD strategy, coordinating cross-functional teams, and contributing to regulatory submissions while guiding SOP development and process improvements.

Qualifications

• PhD in Clinical Pharmacology with extensive experience in PK/PD and drug development.
• Experience leading cross-functional teams in early and late-stage programs.
• Strong ability to mentor junior scientists and drive SOP development.

Responsibilities

• Serve as clinical pharmacology lead on multiple cross-functional project teams and plan strategies.
• Oversee regulatory filings and review pharmacology sections in submissions.
• Support model-based drug development strategies and PK/PD modeling inputs.
• Lead biomarker integration and dose-exposure optimization in early trials.
• Train and manage junior team members within Quantitative Pharmacology.

Skills

Leadership

Strategic thinking

Problem solving

Communication

Mentoring

Data analysis

Education

PhD in Clinical Pharmacology

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a leadership role in Quantitative Pharmacology within the QTR department to oversee clinical pharmacology activities and mentor junior scientists across all stages of development.

The role includes leading PK/PD strategy, coordinating cross-functional teams, and contributing to regulatory submissions while guiding SOP development and process improvements.