Lead, Quantitative Pharmacology & Clinical PK/PD

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 169,000 - 253,000; Full time

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking an experienced clinical pharmacology scientist to provide input across small and large molecule drug development in CNS, nephrology, infectious disease and immunology. The role covers pre-IND to regulatory submissions and cross-functional teams to design and interpret PK/PD analyses.

The position requires a PhD/Dr or MS in Clinical Pharmacology with 4+ years of industry experience, expertise in PK/PD modeling, and collaboration with

Qualifications

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands-on experiences in PK and PK/PD analysis using software such as Phoenix NLME, R.
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
• Great working knowledge of formulation development, drug development and clinical development.
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.

Responsibilities

• Supports clinical pharmacology activities related to clinical study design, protocol development, study execution, reporting and interpretation of data.
• Serves as clinical pharmacology lead on cross-functional project teams and support 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), correlation analysis, exposure-response analysis, meta-analysis.
• Works closely with pharmacometrics team and provides input related to analysis and reporting of PK, PK/PD and exposure-response.
• Authors clinical pharmacology sections in regulatory documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans; authors scientific manuscript or other publications.
• Works with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development.
• Works with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations (IVIVC), in vivo PK study and biowaivers for pre- and post-approval formulations.
• Manages clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.

Skills

Clinical pharmacology

PK/PD analysis

Model-based drug development

Regulatory submissions

Cross-functional collaboration

Biopharmaceutics

Pharmacometrics

Phoenix NLME, R

Education

PhD in Clinical Pharmacology

4+ years industry experience

Population PK experience

Tools

Phoenix NLME

R

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking an experienced clinical pharmacology scientist to provide input across small and large molecule drug development in CNS, nephrology, infectious disease and immunology. The role covers pre-IND to regulatory submissions and cross-functional teams to design and interpret PK/PD analyses.

The position requires a PhD/Dr or MS in Clinical Pharmacology with 4+ years of industry experience, expertise in PK/PD modeling, and collaboration with