Please contact me at
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com> for more
information on the below role:
The Senior Scientist will collaborate with team members to identify and define
mechanisms of action, biomarkers and new drug targets. They will help design
clinical pharmacology trials and selecting pharmacokinetic (PK)/pharmacodynamic
(PD) /biomarker assessments throughout development, develop
physiologically-based pharmacokinetic (PB-PK) models, evaluate new formulations
effect on PK. Will conduct PK/PD analysis and reporting, contribute relevant
sections to regulatory filings, work with pharmacometricians to develop PK/PD
models and contribute to commercial strategies.
Key responsibilities
* Contribute to the development and execution of Clinical
Pharmacology strategy for given programs
* Collaborate with clinical development to design and implement
early clinical development strategies (first-in-man through proof of concept
Phase Ib/Phase 2a)
* Identify new drug targets and biomarkers
* Work on development of physiologically-based pharmacokinetic
models
* responsible for the generation of protocol outlines
* Coordinate with bioanalytical scientists on types methods used to
support clinical trials.
* Analyze PK and PD data using non-compartmental and compartmental
methods
prepares PK and PD sections of study reports and regulatory submissions
documents.
* Partner with pharmacometricians to develop PK/PD/efficacy models.
* represent the PK function at internal and external meetings
Qualifications
* PhD or PharmD
* Minimum of 2-5 years PK/PD experience (can include postdoc work)
* Able to work with minimal supervision and think independently
* Has demonstrated success in technical proficiency, scientific
creativity and collaboration with others.
* Has worked on problems in which analysis of data requires
evaluation of identifiable factors
* Solid understanding of clinical pharmacology with knowledge of
PK/drug metabolism and human physiology
* Ability to create written summaries and presentations using MS
Office (Word, Excel, PowerPoint, Outlook) and Sigma Plot
* Experience with PK/PD software (e.g., WinNonlin) and plotting
software (e.g., R, SigmaPlot,
[cid:1.1213385771@web31815.mail.mud.yahoo.com]
Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
[cid:image001.png@01CBC1F8.25033B10]
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