PK Scientist

As a PK Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will perform protocol writing of Phase 1 clinical pharmacology studies, pharmacokinetic and/or pharmacodynamic analysis using non-compartmental methods, and reporting for clinical trials. Responsibilities include: For clinical pharmacology trial protocols, author the protocol and coordinate the overall development of the protocol with study team members, and ensure timely approval and issuance of the document. Provide QC review of protocols as needed. Review dataset requirements (i.e., trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA). Write the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol. Generate a logbook with data handling rules prior to the final NCA. Perform preliminary, interim, and final PK, PD, and/or PK/PD analysis for trials in all phases of drug development. Creation of tables, listing and figures based on the CPAP. Draft the clinical pharmacology sections of the Clinical Study Report. QC of analysis, all delivered outputs, and of documents reporting the analysis.