Remote Lead, Quantitative Pharmacology & PK/PD

Otsuka America Pharmaceutical Inc.; Baton Rouge (LA); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical benefits

Job summary

Otsuka America Pharmaceutical Inc. is seeking a remote, full-time Clinical Pharmacology expert to provide input across small and large molecules during multiple development stages, including IND/PK/PD analyses and regulatory submissions. The role involves modeling, cross-functional teamwork, and interactions with external collaborators.

The candidate will author relevant sections for regulatory documents and contribute to pharmacometrics strategies, PK/PD analyses, and translational planning.

Qualifications

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.

Responsibilities

• Supports clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
• Serves as clinical pharmacology lead on cross-functional project teams and supports model-based drug development strategies for ongoing projects.
• Conducts translational or clinical PK and PK/PD data plotting and analysis, such as noncompartmental analysis (NCA) and exposure–response analysis.
• Works closely with pharmacometrics and provides input related to PK, PK/PD and exposure–response analyses.
• Authors clinical pharmacology sections in regulatory documents for filings including IND/NDA, annual reports, and development plans.
• Collaborates with bioanalytical and formulation development teams on related activities.

Skills

PK/PD analysis

Phoenix NLME

R software

Clinical pharmacology

Communication skills

Education

PhD/PharmD/MS in Clinical Pharmacology

Tools

Phoenix NLME

R

Job description

Otsuka America Pharmaceutical Inc. is seeking a remote, full-time Clinical Pharmacology expert to provide input across small and large molecules during multiple development stages, including IND/PK/PD analyses and regulatory submissions. The role involves modeling, cross-functional teamwork, and interactions with external collaborators.

The candidate will author relevant sections for regulatory documents and contribute to pharmacometrics strategies, PK/PD analyses, and translational planning.