Associate Director, Quantitative Pharmacology, Pharmacometrics

1w1 week ago

Otsuka Pharmaceutical Companies

Princeton, US · Full-time · $169,222 – $253,000

About this role

Supports all pharmacometrics activities related to pre-IND, IND, phase 1-3, PK, PK/PD and regulatory submissions. Conducts analysis, execution and reporting of pharmacometrics studies. Provides input into all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development.

Authors clinical pharmacology and pharmacometrics submission documents. Represents the department at product development team meetings. Conducts pharmacometrics, simulation and modeling activities to inform modeling and simulation efforts across projects.

Interacts with early development and business development team members as well as external collaborators to assess and lead pre-IND and early phase assets. Works with bioanalytical and formulation development groups on PK, PK/PD, sample management, pharmacogenomics, biomarkers, in vivo-in vitro correlations and biowaivers.

Serves as pharmacometrics lead on multiple project teams and supports model-based drug development strategies. Manages pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisitions, SOW and invoice approvals. Engages with clinical pharmacology to support population PK and PK/PD modeling.

Requirements

In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry
Hands-on PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R etc.
Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements
Good working knowledge of formulation development, drug development and clinical development
Current awareness of the latest developments in clinical pharmacology and guidance documents
Strong technical and hands-on experience related to pharmacometrics, population PK and PK/PD modeling
Ability to apply scientific knowledge to further company products, identify core problems, apply insightful analysis, and solve problems effectively
Travel 20%

Responsibilities

Conducts pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data
Conducts population PK, PK/PD and modeling and simulation
Provides pharmacometrics analysis and participates in activities related to analysis and reporting of population PK and PK/PD analyses
Authors pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans
Works with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provides analysis support related to PK and PK/PD
Works with formulation development groups and provides support for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers
Manages pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices
Serves as pharmacometrics lead on multiple project teams and supports model-based drug development strategies