This individual will serve as a contributor in the Preclinical Pharmacokinetics and Pharmacodynamics (PPK/PD) Group. This individual will track project priorities for the group and provide logistical support (eg, drug product requirements) in support of PK studies at CROs, will work with the preclinical immunoassay group to ensure transparency of data transfer/sharing and will follow all SOPs to ensure GLP compliance. This person will contribute to the protocol design and study operations for all Pharmacokinetic/Toxicokinetic studies, and may support study data analysis using WinNonLin and other similar programs.
- Independently executes broad array of work supporting department priorities in routine Pharmacometrics deliverables on study design, data analysis and reporting.
- Support CRO Studies, track study DS/DP requirements and track project priorities for the group
- Performs descriptive data analyses for study reports and publications as applicable; may perform non-compartmental PK and compartmental PK/PD analyses, according to GxP as appropriate.
- May provide PK data analysis to support BLA Filings
- Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
- Bachelor’s degree (B.S.) in biology or a related field from an accredited college or university with a minimum of two years of post-degree laboratory experience necessary
- An understanding of pharmacokinetics concepts and techniques
- Experience in animal pharmacology, PK or TK studies, including protocol design & study conduct
- Good time management skills to ensure that key data is turned around to meet critical deadlines
- Good communication skills to ensure that key issues are brought to the attention of their supervisor
- Interested in learning to use relevant software, including Phoenix WinNonLin
- Experience in working in a GLP environment and following SOPs