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preclinical PK/PD role with biologics available

From: Brenda Roseberry <broseberry>
Date: Wed, 16 Oct 2019 17:29:44 +0000

New east coast role available in preclinical PK/PD with biologics. Please c=
ontact me if interested at broseberry>
Full time salary and benefits

This position will be responsible for pharmacokinetics (PK) and toxicokinet=
ics (TK) analysis as well as PK/TK and pharmacodynamic (PD) modeling for th=
e discovery and product development programs related to therapeutic monoclo=
nal antibodies and/or other antibody-based molecules. The successful candid=
ate will be responsible for the design of nonclinical PK/TK studies, analys=
is of PK/TK data from nonclinical toxicology studies ( in support of IND-en=
abling and clinical development programs) . Will provide guidance on PK iss=
ues through the stages of product candidate development, provide pharmacolo=
gical modeling of PK/PD data with the goal of developing non-clinical safet=
y and efficacy predictive models.

  * Design and develop PK & PD protocols for nonclinical research and tox=
icology studies
  * Analyze and interpret PK & PD data with modeling and simulation softw=
are, including population PK analyses
  * scaling to predict first-in-human dose (FIH) in support of clinical p=
  * 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 documentsQualif=

  * In-depth understanding of PK principles
  * PhD with training in pharmacokinetics
  * Experience in the design and execution of PK/PD studies with macromol=
ecules, especially antibodies and related molecules
  * In-depth experience with non-compartmental and compartmental PK analy=
sis using WinNonLin
  * Experience in PK/PD modeling and simulation using ADAPT 5, NLME (Phoe=
nix), SimBiology (MATLAB), Berkeley Madonna, etc.-or atleast some of these =
  * Understanding of biotherapeutic drug development and regulatory proce=
  * 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

Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax

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Received on Wed Oct 16 2019 - 13:29:44 EDT

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