New Principal Scientist role available in Clinical Pharmacology. REMOTE. Please
send interest and questions to
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com> must have some
PBPK experience.
Responsible for scientific quality of clinical pharmacology studies: design,
implementation, analysis, interpretation, reporting and regulatory submission.
Will work in collaboration with related disciplines such as clinical,
regulatory, DMPK, statistics, toxicology to support and impact development
decisions. Will partner with relevant KOL's from discovery through
commercialization.
Ensures appropriate PK, PD and PK-PD data analyses are conducted for each
study/program.
Develops PBPK models to support drug development from early to late stage.
Will serve as a key contributor to clinical pharmacology plans and for global
regulatory documents including protocols, investigator's brochures, briefing
documents, IND applications/annual reports, responses to regulatory queries,
CSRs, and Clinical Pharmacology and Biopharmaceutics Summary Documents in
NDAs/MAAs.
Will perform tasks in agreed timelines to insure prompt and accurate execution
of deliverables from clinical pharmacology studies and programs.
Oversees outside vendors as necessary.
Requirements:
PhD or PharmD with 4 plus years of relevant experience ideally in an industry
setting. BS/MS will also be considered with significant experience.
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Brenda Roseberry
Vice President, Scientific Recruiting
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
315-415-4353 - Mobile
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