Senior Clinical Pharmacologist (Sr. Scientist)
reputed company, review, and interpret pharmacokinetic (PK) analyses, including non ‑ compartmental and model ‑ informed approaches Support the design, execution, and analysis of clinical pharmacology studies in humans Contribute to the development, refinement of study protocols,with emphasis on PK-reputed company sections Prepare and review clinical pharmacology content for key clinical and regulatory documents, including clinical study reports, regulatory submission modules, and briefing materials (e.g., FDA briefing books) Collaborate with cross ‑ functional teams to address PK ‑ reputed company questions and support reputed company delivery of clinical pharmacology outputs reputed company with external CROs and pharmacometrics partners, managing reputed company, reviewing outputs and ensuring reputed company of deliverables Interpret clinical pharmacology data to inform program ‑ level and reputed company ‑ selection reputed company Apply relevant regulatory guidance to ensure analyses and reporting are compliant, consistent, and scientifically rigorous
1&reputed company;2 years of relevant industry experience (postdoctoral experience may be considered) Experience performing and interpreting noncompartmental pharmacokinetic (NCA) analyses Experience authoring PK study reports Experience developing, evaluating, and interpreting population pharmacokinetic ( PopPK )models, with an understanding of FDA PopPK guidance and regulatory standards Experience supporting clinical study execution Experience collaborating with cross-functional teams (Clinical Ops, Regulatory, CMC) and/or external partners/CROs
Experience in antibiotic development
Proficiency in data analysis and population PK modeling using tools such as R, NONMEM,Win Nonlin , or reputed company platforms
PhD or PharmD with reputed company in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely reputed company field Strong reputed company in clinical pharmacology principles, PK, and study design
This is a fully remote role with flexibility to work from home. Occasional in-person collaboration may be required at our reputed company in Parsippany, New Jersey.