Director, Pharmacometrics-Bay area, CA
Description:
Help apply quantitative analysis methods and PK/PD modeling techniques in
developing candidate drug products through clinical development. Serve as an
expert to all relevant disciplines and ensure that modeling and simulation
(M&S) methods are utilized optimally in development activities. Plan and
execute PK/PD M&S activities. Represent the Pharmacometrics group in project
team meetings, collaborating with others on the principles and theories of
quantitative evaluation of new products. In collaboration with other members
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 protocols, performing and
supervising pharmacokinetic and pharmacodynamic analyses, and preparation of
clinical study reports and integrated summary documents. Provide feedback and
direction for regulatory submission preparations and review support for new or
existing products. Work closely with clinical operations, biostatistics, data
management, research, drug metabolism, and therapeutics areas. Contribute to
the development and implementation of guidelines and SOPs within the
Pharmacometrics group. Provide scientific/technical guidance, leadership, and
decision-making as appropriate. Provide regular performance feedback,
development, and coaching to direct reports.
Requirements:
A minimum of PhD in pharmacokinetics/pharmacodynamics, pharmacometrics, or
related field is required. A minimum of 8 years of experience in designing,
analyzing, and reporting drug development studies is required. Equivalent
experience may be accepted.. Proficiency in the use of major PK/PD software
such as WinNonlin, Monolix, or NONMEM is required, as is working knowledge of
software used to create graphical output and report study results. Strong
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
development 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 with
colleagues, both internal and external.
Please email me at
[email protected]<mailto:[email protected]> for more info
or call at 315-415-4353
[cid:[email protected]]
Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
[cid:[email protected]]
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