PK Scientist

PK Scientist

ICON

Multiple Locations

About the role

We are seeking an experienced Clinical Pharmacology professional to support protocol development and pharmacokinetic/pharmacodynamic (PK/PD) analysis across Phase I–IV clinical trials as PK Scientist. This role involves protocol writing, non-compartmental analysis (NCA), and clinical pharmacology reporting while collaborating with cross-functional teams within a regulated clinical development environment.

What You Will Be Doing:

• Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance.
• Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods.
• Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA.
• Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs).
• Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements.

Your Profile:

• Bachelor’s degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills.
• 1+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements.
• Working knowledge of data analyses software packages
• Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis (Experience with R is an advantage).
• Basic knowledge of noncompartmental PK analysis and statistical principles
• Understanding of clinical trial data structures and experience collaborating with Data Management, Biostatistics, and CRO partners.