Clinical Pharmacology Lead: PK/PD & Model-Based Dev

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); Híbrido; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive medical, dental, vision

401(k) match

Paid holidays

Paid leave

Descripción de la vacante

Otsuka Pharmaceutical Co., Ltd. is seeking a senior professional to lead clinical pharmacology activities across pre-IND to development stages in the United States.

The role includes study design, protocol development, PK/PD analyses, and regulatory submission input. You will work closely with pharmacometrics, bioanalysis, formulation, and development teams, mentoring staff and guiding model-based drug development strategies.

Formación

• In-depth knowledge of clinical pharmacology and PK/PD analyses.
• Experience with regulatory filings and drug development.
• Ability to lead cross-functional teams and mentor staff.

Responsabilidades

• Design and oversee clinical pharmacology studies and PK/PD analyses.
• Prepare pharmacology sections for regulatory submissions and reports.
• Lead modeling and simulation activities and collaborate with pharmacometrics.

Conocimientos

Leadership

Organization

Communication

Clinical pharmacology

Educación

PhD/PharmD/MS in Clinical Pharmacology

Herramientas

Phoenix NLME

Descripción del empleo

Otsuka Pharmaceutical Co., Ltd. is seeking a senior professional to lead clinical pharmacology activities across pre-IND to development stages in the United States.

The role includes study design, protocol development, PK/PD analyses, and regulatory submission input. You will work closely with pharmacometrics, bioanalysis, formulation, and development teams, mentoring staff and guiding model-based drug development strategies.