Senior Director, Quantitative Pharmacology & PK/PD Strategy

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

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

Generous 401(k) match

Paid holidays & paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a Clinical Pharmacology Lead within the Quantitative Pharmacology group to guide PK/PD strategy, oversee regulatory submissions, and mentor junior scientists across all development stages.

You will partner with pharmacometrics, biomarker, non-clinical toxicology, and regulatory teams to optimize dose selection, exposure-response analyses, and pediatric development plans while aligning with overall development strategy.

Qualifications

• PhD in Clinical Pharmacology (or related area) with a minimum of 12 years of experience in these areas.
• Experience in early-phase clinical protocol development is a plus.

Responsibilities

• Serve as clinical pharmacology lead on cross-functional project teams and develop strategies for clinical development plans.
• Review and approve pharmacology sections for regulatory filings (IND/NDA/BLA) and pediatrics development plans.
• Collaborate with pharmacometrics and biomarker teams to support MIDD, PK/PD modeling, and dose selection.
• Mentor junior scientists and lead capacity-building within Quantitative Pharmacology.

Skills

Travel 20-40%

Leadership/mentorship

Education

PhD in Clinical Pharmacology (or related area)

Job description

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a Clinical Pharmacology Lead within the Quantitative Pharmacology group to guide PK/PD strategy, oversee regulatory submissions, and mentor junior scientists across all development stages.

You will partner with pharmacometrics, biomarker, non-clinical toxicology, and regulatory teams to optimize dose selection, exposure-response analyses, and pediatric development plans while aligning with overall development strategy.