Please contact me at broseberry_at_cartermackay.com<mailto:broseberry_at_carterma=
ckay.com> for more information on the below role:
The Senior Scientist will collaborate with team members to identify and def=
ine mechanisms of action, biomarkers and new drug targets. They will help d=
esign clinical pharmacology trials and selecting pharmacokinetic (PK)/pharm=
acodynamic (PD) /biomarker assessments throughout development, develop phys=
iologically-based pharmacokinetic (PB-PK) models, evaluate new formulations=
effect on PK. Will conduct PK/PD analysis and reporting, contribute releva=
nt 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 Pharm=
acology strategy for given programs
* Collaborate with clinical development to design and implement=
early clinical development strategies (first-in-man through proof of conc=
ept 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 use=
d to support clinical trials.
* Analyze PK and PD data using non-compartmental and compartmen=
tal methods
prepares PK and PD sections of study reports and regulatory submissions doc=
uments.
* Partner with pharmacometricians to develop PK/PD/efficacy mod=
els.
* represent the PK function at internal and external meetings
Qualifications
* PhD or PharmD
* Minimum of 2-5 years PK/PD experience (can include postdoc w=
ork)
* 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 eva=
luation of identifiable factors
* Solid understanding of clinical pharmacology with knowledge o=
f PK/drug metabolism and human physiology
* Ability to create written summaries and presentations using M=
S 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_at_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_at_01CBC1F8.25033B10] <
http://www.linkedin.com/profile/vi=
ew?id=19937880&authType=name&authToken=b5d_>
Received on Thu Nov 07 2019 - 11:42:31 EST
