The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies including: protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating the in-text tables and figures and PK/PD attachments for clinical study reports
Job Summary
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies including: protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating the in-text tables and figures and PK/PD attachments for clinical study reports.
Main Accountabilities include authoring CP sections of protocols, performing pre-DBL, interim, and final NCA for trials in all phases of drug development, and preparing final NCA output including in-text tables and graphs for the Clinical Study Report.
The role requires establishing and maintaining excellent/cooperative relationships with other departments to facilitate on-time deliverables and carrying out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Matching Summary
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies including: protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating the in-text tables and figures and PK/PD attachments for clinical study reports.
Skills & Requirements
Must-have
Clinical Pharmacokinetics
Pharmacokinetic/Pharmacodynamic data analysis
Protocol development
Phoenix WinNonlin
Noncompartmental analysis (NCA)
Nice-to-have
Work effectively in matrix environment
Mentor junior scientists
Familiar with regulatory guidelines
Cooperative relationships with other departments
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)