Title: Principal PK Scientist (home-based, East Coast)
Department: Drug Development
Location: USA - Maryland - Baltimore
Employment Type: Full Time
Job Type: Regular
Req Number: pare-10021154
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
This position can be home-based on the East Coast
Travel up to 10%
- To analyze clinical PK/PD data as a member of several multidisciplinary development program teams.
- To work with our clinical team to design PK components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies. The selected individual will be responsible for authoring or contributing to clinical PK/PD sections of relevant documents.
- Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated pharmacokinetic and pharmacodynamic modeling and simulation initiatives, including population pharmacokinetic/pharmacodynamic analyses for both phase I and late phase clinical trials
- To provide training and scientific support and advice to all Early Phase staff
- Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
- Quality control of pharmacokinetic output from WinNonlin analysis
- Review of derived PK data generated by PK Analyst
- To attend client meetings and represent PK/PD aspects as needed
Science degree or preferably higher scientific qualification with:
- Strong Knowledge of drug pharmacokinetics
- Experience in Pharsight Software (WinNonlin/Phoenix)
- Understanding of pharmacokinetic, and PK/PD modeling strategies
- Experience in NONMEM (population pharmacokinetics)required
- Experience in early clinical drug development of both NCEs and biologicals
PAREXEL International - 2 years ago
PAREXEL International excels in pharmaceutical development services. A top contract research organization (CRO), the firm counts among its...