NONMEM Users Network Archive

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new role in CA bay area

From: Brenda Roseberry <broseberry>
Date: Wed, 26 Aug 2020 19:52:34 +0000

Mid level clinical pharmacology role available in the bay area. Please emai=
l me at broseberry
 more info. (permanent, full time salary and benefits provided, relocation=
 is also provided if needed)

This position will assist in developing and applying clinical pharmacology =
and translational medicine strategies for candidate drug products from firs=
t in human through late stage development (Phase 3 and NDA/BLA filings) usi=
ng PK, PD, DMPK, scientific acumen and knowledge of drug development proces=
ses along with regulatory guidance. Key skills and responsibilities include=
:
* Representing clinical pharmacology department on cross-functional project=
 teams
* Collaborate with other disciplines for the optimal design of Phase I-IV s=
tudies; including clinical study protocols and reports.
* Collaborate with the bioanalytical team for the proper collection and tes=
ting of relevant PK/biomarker samples.
* Assist in the preparation of clinical pharmacology reports and regulatory=
 documents (IND, IMPD, IB, NDA CTD, etc).
* Perform data analysis such as non-compartmental and compartmental PK/PD a=
nalysis.
* Work closely with pharmacometricians
* Contribute to the writing of publications and making scientific presentat=
ions consistent with development strategies.
* Maintain knowledge of relevant scientific and regulatory practices and tr=
ends, and ensure that clinical pharmacology aspects of development programs=
 are contemporary. Other duties as assigned.

A PhD or PharmD in a scientific discipline is required. A minimum of 3 year=
s work experience in an industry research and/or development environment is=
 required. Post-doctoral work may serve as experience. Exceptional non-Ph=
Ds may also be considered. Must be able to demonstrate significant success=
 in technical knowledge and ability, scientific creativity, collaboration w=
ith other scientists and independent thought. Must be able to clearly commu=
nicate scientific and technical information both written and verbally. Must=
 be able to demonstrate sound judgment and problem-solving capabilities. St=
rong organizational skills are required. Experience working in an FDA regul=
ated environment and experience and understanding of ICH, and GCP is highly=
 desired. Must have hands-on experience with data analysis, non-compartment=
al and compartmental PK/PD analysis and using data processing software such=
 as Phoenix WinNonlin, R, NONMEM, and/or MONOLIX. Good working knowledge of=
 graphing software is also desired.
[cid:1.1213385771
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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-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=tr=
ue>



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Received on Wed Aug 26 2020 - 15:52:34 EDT

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