At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Position Summary :
The Senior Clinical Pharmacokineticist / Pharmacometrician functions as the Global clinical pharmacology and DMPK (CPD) Project Lead or Pharmacometrics expert for biotherapeutic products at various stages of research and clinical development.
perform non-compartmental PK analysis, dataset preparation for NONMEM analysis, NONMEM analysis and technical report writing, and communication of data in regulatory documents and meetings.
The Senior Clinical Pharmacokineticist / pharmacometrician is also expected to use advanced PKPD modeling tools to support the therapeutic target evaluation, the design of in vivo animal efficacy studies, dose recommendation for clinical studies, the assessment of clinical PKPD and the relationship with clinical response.
Major Duties and Responsibilities :
contribute to the clinical study protocols and reports.
Perform population- and / or mechanism-based modeling to characterize the PK and PD of candidate drugs. Perform exposure-response analysis and clinical trial simulations to support development decisions.
Education & Experience :
5 years with MS) for Clinical Pharmacokineticist
Special Requirements :
Strong analytical and technical writing skills are required for this position. Good communication / organization skills, a full understanding of basic PK concepts, and familiarity with WinNonlin and GxP regulations.
Strong modeling / simulation experience and knowledge of NONMEM, Splus / R are highly desirable.
Job Complexity :
Prior training in statistics, numerical method and computer programming is a plus.