Executive Lead, Clinical Pharmacology & Quantitative PK/PD

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid holidays and leave

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Clinical Pharmacology Lead to oversee pharmacology activities across all phases of drug development. You will mentor a growing team, coordinate cross-functional efforts, and drive strategy for regulatory submissions and PK/PD analyses.

The role emphasizes leadership in early- and late-stage development, collaboration with pharmacometrics and biomarker teams, and the advancement of SOPs and cross-functional processes within the QTR division.

Qualifications

• PhD in Clinical Pharmacology with a minimum of 12 years of experience in these areas. Early-phase clinical protocol development experience is a plus.

Responsibilities

• Serve as clinical pharmacology lead on cross-functional project teams and plan/optimize strategies across development plans.
• Review and lead development of clinical pharmacology sections for regulatory filings (IND/NDA/BLA) and pediatrics plans.
• Collaborate with pharmacometrics to support MIDD strategies and PK/PD modeling for dose selection.
• Support biomarker development and incorporation into early-phase studies.
• Oversee interactions with nonclinical pharmacology/toxicology, ADME, regulatory, and CMC teams; mentor junior staff.

Skills

Travel

Leadership

Mentoring

Education

PhD in Clinical Pharmacology

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Clinical Pharmacology Lead to oversee pharmacology activities across all phases of drug development. You will mentor a growing team, coordinate cross-functional efforts, and drive strategy for regulatory submissions and PK/PD analyses.

The role emphasizes leadership in early- and late-stage development, collaboration with pharmacometrics and biomarker teams, and the advancement of SOPs and cross-functional processes within the QTR division.