Mid level clinical pharmacology role available in the bay area. Please email me
at [email protected]<mailto:[email protected]> for 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 first in
human through late stage development (Phase 3 and NDA/BLA filings) using PK,
PD, DMPK, scientific acumen and knowledge of drug development processes 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
studies; including clinical study protocols and reports.
* Collaborate with the bioanalytical team for the proper collection and testing
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
analysis.
* Work closely with pharmacometricians
* Contribute to the writing of publications and making scientific presentations
consistent with development strategies.
* Maintain knowledge of relevant scientific and regulatory practices and
trends, 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 years
work experience in an industry research and/or development environment is
required. Post-doctoral work may serve as experience. Exceptional non-PhDs
may also be considered. Must be able to demonstrate significant success in
technical knowledge and ability, scientific creativity, collaboration with
other scientists and independent thought. Must be able to clearly communicate
scientific and technical information both written and verbally. Must be able to
demonstrate sound judgment and problem-solving capabilities. Strong
organizational skills are required. Experience working in an FDA regulated
environment and experience and understanding of ICH, and GCP is highly desired.
Must have hands-on experience with data analysis, non-compartmental 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:[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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