Pharmacokineticist, PPK/PD
Core
Senior independent contributor leading end-to-end non-compartmental and compartmental PK/PD analyses for nonclinical and clinical studies, preparing regulatory datasets, and supporting CRO studies.
Role type
Senior IC pharmacokineticist (PPK/PD)
Builds
Regulatory submission datasets, pharmacometrics deliverables, and study reports for life-changing medicines.
Domain
Biopharmaceuticals / Pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Non-compartmental PK analysis, compartmental PK/PD modeling, CDISC SEND dataset preparation, CRO study support, SOP compliance, regulatory table/listing generation, graphical output creation
Preferred skills
NLME/population PK modeling, R programming
Technologies
Phoenix WinNonlin, R
Responsibilities
Lead and execute PK/PD analyses for nonclinical and clinical studies; prepare and quality-control standardized CDISC SEND datasets for regulatory submission; support CRO studies and serve as primary PK point of contact; produce regulatory tables, listings, and figures; author and review SOPs to ensure GxP/GLP compliance; mentor junior analysts.
Seniority
Senior, hands-on IC
