Responsibilities include:
1. With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
2. Under direction, provide protocol study design input and assist in the development of clinical study monitoring plans, site selection, and PK samples logistics.
3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III PK and PK/PD studies.
4. Assist in the development of the statistical analysis plan.
5. Assist in the analysis and reporting population-pharmacokinetic and PK/PD data as necessary to describe pharmacokinetics in patient population.
6. With guidance, provide scientific oversight of CROs with respect to PK and PK/PD tasks.
7. Under direction, evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity to late stage Phase 3 drug development.
8. Under direction, provide PK and PK/PD strategies to compounds under drug development for global regulatory submission.

Qualifications
Prerequisites:
Advanced degree (Pharm.D. or Ph.D.) in pharmacokinetics/pharmacology or relevant
life sciences, with 0 to 2-years experience conducting and analyzing pharmacokinetic
and pharmacodynamic studies in humans.
Skills/Knowledge Required:
 Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics and 0 to 2-years of experience conducting clinical pharmacology trials including analyzing and writing human pharmacokinetic studies.
 Good knowledge of pharmacokinetics (ADME principles) and pharmacology concepts
 Basic knowledge of PK/PD data analyses, ie. population and exposure-response analyses.
 Basic knowledge of the use of clinical pharmacokinetics for designing first-in-human studies and providing PK strategies for late phase registration studies.
 Computer literate: familiarity with WinNonlin or equivalent.
 Good knowledge of Microsoft Word, Excel, and PowerPoint.
 Good written and oral presentation skills.
 Ability to work in a matrix, project-oriented environment.
 Ability to organize and work simultaneously on multiple projects.
 Knowledge on clinical data base, PK/PD data compilation and manipulation with scripting softwares of NONMEM, SAS, Splus and/or R a plus