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, developing Clinical Pharmacology Analysis Plans, performing non-compartmental analysis (NCA) across all study phases, and creating data review documents.
The role requires establishing and maintaining cooperative relationships with other departments, carrying out responsibilities according to SOPs and regulatory requirements, and mentoring 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 Pharmacokinetics
PK/PD analysis
Phoenix WinNonlin
Protocol development
Clinical Study Reports
Nice-to-have
Matrix environment management
Mentoring junior scientists
Regulatory guidelines application
Data handling rules creation
Key Requirements
Minimum 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)