Lead, Quantitative Pharmacology & Clinical PK (Remote)

Otsuka America Pharmaceutical Inc.; Harrisburg (Dauphin County); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. in the United States is seeking a senior Clinical Pharmacology professional to provide input across pre-IND through phase 3 drug development, spanning CNS, nephrology, infectious disease and immunology areas.

You will lead PK/PD analyses, support regulatory submissions, and collaborate with pharmacometrics, nonclinical, and bioanalytical teams. The role covers study design, translational PK, mass balance and DDI studies, authoring sections for regulatory

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, etc.
• 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

Phoenix NLME

R

Cross-functional collaboration

Regulatory submissions

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

R

Job description

Otsuka America Pharmaceutical Inc. in the United States is seeking a senior Clinical Pharmacology professional to provide input across pre-IND through phase 3 drug development, spanning CNS, nephrology, infectious disease and immunology areas.

You will lead PK/PD analyses, support regulatory submissions, and collaborate with pharmacometrics, nonclinical, and bioanalytical teams. The role covers study design, translational PK, mass balance and DDI studies, authoring sections for regulatory