Principal Pharmacokinetics Scientist -(Permanent Remote role)
Core
Lead study concept and protocol design for clinical pharmacology studies, conducting PK/PD and Pop PK-PD analyses to support regulatory filings and clinical trials.
Role type
Principal Pharmacokinetics Scientist (Clinical Pharmacology)
Builds
Clinical pharmacology development plans, modeling and simulation plans, PK/PD analysis reports
Domain
Pharmaceutical/Biotechnology Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
PK/PD theory and practice, study concept development, protocol design, clinical pharmacology development plans, Pop PK-PD analysis, regulatory compliance knowledge, Phoenix WinNonlin, NLME, R/R Studio, Monolix, NONMEM, mentorship
Preferred skills
Experience across multiple therapeutic areas, CRO environment experience, relevant certifications
Technologies
Phoenix WinNonlin, NLME, R/R Studio, Monolix, NONMEM
Responsibilities
Lead study concept and protocol design, conduct PK-PD and Pop PK-PD analyses, provide technical expertise in PK/PD software, collaborate with clients on clinical pharmacology needs, prepare and review PK/PD analysis reports, apply knowledge of pharmaceutical regulatory requirements, mentor junior pharmacologists
Seniority
Principal, hands-on IC with leadership
