Senior Clinical Pharmacokinetist
AstraZeneca
Macclesfield, England, United Kingdom
1d ago

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.

  • The Senior Clinical Pharmacokineticist / Pharmacometrician will be responsible for all aspects of PK-related support for biotherapeutic products, including design of studies, analysis and preparation of reports and protocols;
  • 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 :

  • Represent Global CPD on cross-functional project teams involved in the nonclinical and clinical development of biotherapeutics.
  • Provide functional inputs on scientific discussion relating to PK, PD, target population, and dose / regimen selection to project teams.
  • Plan, coordinate, initiate, and monitor outsourced PK / PD study; review and finalize study reports
  • Collaborate with toxicologists on the design and reporting of nonclinical safety studies.
  • Prepare PK / PD and bioanalytical sub-reports for outsourced studies; review and finalize study reports.
  • Collaborate with biostatisticians, clinicians and clinical operation managers for the optimal design of clinical studies through all the phases;
  • contribute to the clinical study protocols and reports.

  • Use translational simulations to project the human PK / PD for the starting-dose selection for first-in-human studies.
  • 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.

  • Prepare relevant sections of regulatory documents; participate in regulatory meetings if requested.
  • Comply with GxP regulations for GxP studies.
  • Present and report data in approved external meetings and publications.
  • Education & Experience :

  • PhD in pharmaceutical sciences or a related field (minimal 3 years of relevant experience) for Senior Clinical Pharmacokineticist
  • PhD, MS in pharmaceutical science or a related field (0-3 years with PhD, and >
  • 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 :

  • Familiarity with standard noncompartmental data analysis software. Experience with standard population modeling and associated software (NONMEM, R / Splus, SAS) is highly desirable.
  • Prior training in statistics, numerical method and computer programming is a plus.

  • Good communication skills and ability to work in a cross-functional team environment; Experience in regulatory filings and knowledge of GxP regulation are desired
  • Ability to work independently with minimal supervision
  • Apply
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