Senior Scientist Clinical Pharmacokinetics

Johnson & Johnson Innovative Medicine

High Wycombe, United Kingdom
Clinical pharmacokinetics
Pharmacokinetic/pharmacodynamic data analysis
Non-compartmental analysis (nca)
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role is responsible for end-to-end Phase 1 study execution, including protocol development, PK/PD data analysis, and generating reports for clinical study reports and regulatory submissions

Job Summary

  • The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role is responsible for end-to-end Phase 1 study execution, including protocol development, PK/PD data analysis, and generating reports for clinical study reports and regulatory submissions.
  • Key accountabilities include authoring protocol sections, performing PK/PD NCA for all study phases, preparing final NCA outputs, and developing CPP sections for CSRs.
  • The role requires establishing cooperative relationships with other departments, mentoring junior scientists, and ensuring compliance with SOPs and regulatory requirements.

Matching Summary

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

Skills & Requirements

Must-have

  • Clinical Pharmacokinetics
  • Pharmacokinetic/Pharmacodynamic data analysis
  • Non-compartmental analysis (NCA)
  • Phoenix WinNonlin
  • Protocol development
  • Clinical Study Reports (CSR)

Nice-to-have

  • Matrix environment management
  • Mentoring junior scientists
  • Literature search and summarization
  • Regulatory guidelines application

Key Requirements

  • Minimum of 4 years of clinical experience
  • Bachelor’s degree or higher
  • Knowledge of PK, PD, and statistical principles
  • Working knowledge of database structures (e.g. SDTM, ADaM)
  • Experience with R is preferred

Work Rights

Not specified

Tailored Resume

Cover Letter