Senior Director, Clinical Pharmacology & PK/PD Modeling

Otsuka America Pharmaceutical Inc.; Atlanta (GA); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Otsuka America Pharmaceutical Inc. is seeking a highly experienced Clinical Pharmacologist to provide input across early and late drug development in multiple modalities.

You will lead PK/PD modeling, design studies, and author sections for regulatory submissions while collaborating with pharmacometrics, nonclinical, and biostatistics teams. You will drive translational pharmacology efforts, ensure robust data interpretation, and support interactions with global teams to advance assets through

Qualifications

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands-on PK/PD analysis using software such as Phoenix NLME and R.
• Experience with phase I operations and multi-region regulatory requirements in PK/PD analysis.
• Knowledge of formulation development and clinical development processes.

Responsibilities

• Support study design, protocol development, study execution, reporting and interpretation of data.
• Lead cross-functional project teams as clinical pharmacology lead and support model-based drug development strategies.
• Conduct PK/PKPD analyses including NCA, exposure–response, and meta-analysis.
• Collaborate with pharmacometrics and bioanalytical teams on PK/PD reporting.
• Authors regulatory sections and scientific manuscripts; support early asset assessment and development planning.

Skills

Clinical pharmacology

PK/PD analysis

Pharmacometrics

R (statistics)

Phoenix NLME

Drug development

Education

PhD/PharmD/MS in Clinical Pharmacology (or related)

Tools

Phoenix NLME

R

Job description

Otsuka America Pharmaceutical Inc. is seeking a highly experienced Clinical Pharmacologist to provide input across early and late drug development in multiple modalities.

You will lead PK/PD modeling, design studies, and author sections for regulatory submissions while collaborating with pharmacometrics, nonclinical, and biostatistics teams. You will drive translational pharmacology efforts, ensure robust data interpretation, and support interactions with global teams to advance assets through