Head of Quantitative Pharmacology & Clinical PK/PD

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); Vor Ort; USD 169.000 - 253.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid holidays

Tuition reimbursement

Zusammenfassung

Otsuka Pharmaceutical Companies (U.S.) in New Jersey is seeking a senior clinical pharmacology leader to drive PK/PD analyses, pharmacometrics, and regulatory submissions for IND/NDAs. You will partner with non-clinical, bioanalytical, formulation and early development teams to shape development strategies and pediatric plans.

The role requires advanced degree and 5+ years in clinical pharmacology with strong leadership, communication and cross-functional collaboration.

Qualifikationen

• In-depth knowledge of clinical pharmacology, PK/PD and bioanalytical chemistry.
• Experience in phase I operations, multi-region regulatory requirements, PK/PD analysis.
• Leadership in clinical pharmacology and strong communication skills.

Aufgaben

• Conduct PK and PK/PD analysis.
• Author regulatory submission sections including IND/NDA documentation.
• Lead pharmacometrics and modeling plans; provide input on modeling strategies.

Kenntnisse

Clinical pharmacology

PK/PD analysis

Biopharmaceutics

Bioanalytical chemistry

Leadership experience

Communication skills

Ausbildung

PhD/PharmD/MS in Clinical Pharmacology

Tools

Phoenix NLME

Jobbeschreibung

Otsuka Pharmaceutical Companies (U.S.) in New Jersey is seeking a senior clinical pharmacology leader to drive PK/PD analyses, pharmacometrics, and regulatory submissions for IND/NDAs. You will partner with non-clinical, bioanalytical, formulation and early development teams to shape development strategies and pediatric plans.

The role requires advanced degree and 5+ years in clinical pharmacology with strong leadership, communication and cross-functional collaboration.