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Director, Pharmacometrics, Bay area California role available

From: Brenda Roseberry <broseberry>
Date: Thu, 17 Jan 2019 18:01:58 +0000

Director, Pharmacometrics-Bay area, CA

Help apply quantitative analysis methods and PK/PD modeling techniques in d=
eveloping candidate drug products through clinical development. Serve as a=
n expert to all relevant disciplines and ensure that modeling and simulatio=
n (M&S) methods are utilized optimally in development activities. Plan and=
 execute PK/PD M&S activities. Represent the Pharmacometrics group in proj=
ect team meetings, collaborating with others on the principles and theories=
 of quantitative evaluation of new products. In collaboration with other m=
embers of project teams, make decisions impacting PK/PD analysis goals and =
the success and relevance of individual studies. Contribute to the design =
and preparation of pharmacokinetics development strategies and study protoc=
ols, performing and supervising pharmacokinetic and pharmacodynamic analyse=
s, and preparation of clinical study reports and integrated summary documen=
ts. Provide feedback and direction for regulatory submission preparations =
and review support for new or existing products. Work closely with clinica=
l operations, biostatistics, data management, research, drug metabolism, an=
d therapeutics areas. Contribute to the development and implementation of=
 guidelines and SOPs within the Pharmacometrics group. Provide scientific/t=
echnical guidance, leadership, and decision-making as appropriate. Provide =
regular performance feedback, development, and coaching to direct reports.

A minimum of PhD in pharmacokinetics/pharmacodynamics, pharmacometrics, or=
 related field is required. A minimum of 8 years of experience in designin=
g, analyzing, and reporting drug development studies is required. Equivalen=
t experience may be accepted.. Proficiency in the use of major PK/PD softwa=
re such as WinNonlin, Monolix, or NONMEM is required, as is working knowled=
ge of software used to create graphical output and report study results. St=
rong written and verbal communication skills are required; must be able to =
independently create high quality written reports and summary documents for=
 use in regulatory submissions. Desire to work in a cross-functional drug d=
evelopment team environment with all levels of employees and management is =
valued. Must be goal-oriented, quality-conscientious, and project-focused, =
with demonstrated ability to develop successful influential relationships w=
ith colleagues, both internal and external.
Please email me at broseberry> for more info or call at 315-415-4353

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 Thu Jan 17 2019 - 13:01:58 EST

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