New roles available, bay area CA, level flexible. Relo provided, also flexible
during COVID. Please email me for more info at
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com>
This position will assist in developing and applying clinical pharmacology and
translational medicine strategies for candidate drug products including from
FIH through late stage development and regulatory filing.
* Represent clinical pharmacology on cross-functional project teams
involved in the clinical development of candidate drug products.
* Collaborate with cross functional teams for the optimal design of
Phase I-IV studies; contribute to the clinical study protocols and reports.
* Work closely with sample management and bioanalytical.
* Assist in integrating and interpreting nonclinical and clinical
pharmacology, DMPK, and translational medicine pricniples in the preparation of
clinical pharmacology write-ups and regulatory documents (IND, IMPD, IB, NDA
CTD, etc).
* Create and manage of datasets such as non-compartmental and
compartmental PK/PD analysis.
* Collaborate with pharmacometricians in the modeling of emerging
PK and PK/PD data.
* Participate in writing 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 Pharm. D. or PhD in a scientific discipline is required. Post-doctoral work
may serve as experience. non-PhDs with demonstrated capabilities and/or
significant experience may also be considered. Must be able to demonstrate
significant success in technical proficiency, scientific creativity,
collaboration with others and independent thought and be able to clearly
communicate scientific and technical information both written and oral.
Experience working in an 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 and using data processing
software such as Phoenix WinNonlin, R, NONMEM, etc. Good working knowledge of
graphing software is also desired.
[cid:1.1213385771@web31815.mail.mud.yahoo.com]
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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