Senior Scientist Clinical Pharmacokinetics

Johnson & Johnson

Beerse, Belgium
Clinical pharmacology and pharmacometrics
Protocol development
Pk/pd data analysis
The Senior Scientist Clinical Pharmacokinetics role is responsible for end-to-end Phase 1 study execution, including protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating reports for clinical study reports and regulatory submissions

Job Summary

  • The Senior Scientist Clinical Pharmacokinetics role is responsible for end-to-end Phase 1 study execution, including protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating reports for clinical study reports and regulatory submissions.
  • Key accountabilities include authoring protocol sections, reviewing data transfer agreements, performing noncompartmental analysis for all study phases, and developing Clinical Pharmacology sections for Clinical Study Reports.
  • This role requires collaboration with various departments to ensure timely deliverables and adherence to SOPs, regulatory requirements, and Johnson & Johnson Credo principles, with opportunities to mentor junior scientists.

Matching Summary

The Senior Scientist Clinical Pharmacokinetics role is responsible for end-to-end Phase 1 study execution, including protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating reports for clinical study reports and regulatory submissions.

Skills & Requirements

Must-have

  • Clinical Pharmacology and Pharmacometrics
  • Protocol development
  • PK/PD data analysis
  • Noncompartmental analysis (NCA)
  • Phoenix WinNonlin experience

Nice-to-have

  • Work effectively in matrix environment
  • Mentor junior scientists
  • Familiar with regulatory guidelines
  • General understanding of drug development

Key Requirements

  • Bachelor’s degree or higher
  • Minimum of 4 years clinical experience
  • Knowledge of PK, PD, and statistical principles
  • Working knowledge of database structures
  • R experience preferred

Work Rights

Not specified

Tailored Resume

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