New east coast role available in preclinical PK/PD with biologics. Please
contact me if interested at
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com>
Full time salary and benefits
This position will be responsible for pharmacokinetics (PK) and toxicokinetics
(TK) analysis as well as PK/TK and pharmacodynamic (PD) modeling for the
discovery and product development programs related to therapeutic monoclonal
antibodies and/or other antibody-based molecules. The successful candidate will
be responsible for the design of nonclinical PK/TK studies, analysis of PK/TK
data from nonclinical toxicology studies ( in support of IND-enabling and
clinical development programs) . Will provide guidance on PK issues through the
stages of product candidate development, provide pharmacological modeling of
PK/PD data with the goal of developing non-clinical safety and efficacy
predictive models.
* Design and develop PK & PD protocols for nonclinical research and
toxicology studies
* Analyze and interpret PK & PD data with modeling and simulation software,
including population PK analyses
* scaling to predict first-in-human dose (FIH) in support of clinical
protocols
* clinical dose projections
* Contribute to the development of clinical protocols
* Serve as the PK expert on research and product development teams
* Author relevant PK reports and sections of regulatory
documentsQualifications:
Required
* In-depth understanding of PK principles
* PhD with training in pharmacokinetics
* Experience in the design and execution of PK/PD studies with
macromolecules, especially antibodies and related molecules
* In-depth experience with non-compartmental and compartmental PK analysis
using WinNonLin
* Experience in PK/PD modeling and simulation using ADAPT 5, NLME
(Phoenix), SimBiology (MATLAB), Berkeley Madonna, etc.-or atleast some of these
softwares
* Understanding of biotherapeutic drug development and regulatory processes
* Excellent organizational skills
* Strong interpersonal skills
* Proven ability to work in a multi-disciplinary team setting
* Excellent verbal and written communication skills
* A passion for discovery, good science and drug development
[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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