Please send resumes and questions to
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com>
Director, clinical pharmacology and pharmacometrics will be responsible to lead
projects from early through late-stage clinical development including phase 3
and beyond with an emphasis on clinical dose selection/refinement as well as
predictive PK/PD modeling. This will include population and statistically-based
methodologies, as well as mechanistic and translational-focused approaches.
This role has a highly strategic component but will also include some hands on
work in combination with junior scientists and select vendor partners. This is
a highly visible and team-facing role.
Responsibilities Include
* Will be a lead authority on clinical pharmacology and pharmacometrics
strategy across all stages of drug development
* Will serve as departmental and company expert in clinical and
translational strategies, protocol preparation, study execution, data review
and analysis, and study reports
* Responsible for model-based data analysis including population PK,
PK/PD modeling and simulation, disease modeling, and meta analysis to inform
clinical development
* Will be the functional lead for global regulatory strategies and
health authority engagement
* Expected to maintain up to date knowledge in clinical pharmacology
and pharmacometrics disciplines including new strategies/technology/software,
manuscript publication, presentations at scientific conferences and meetings
* serve as a mentor to junior scientists
Requirements include
* PhD in Pharmaceutical Sciences, mathematics/engineering or related
field
* 7+years of experience working in clinical pharmacology and
pharmacometrics
* Strong understanding of clinical pharmacology principals
* Strong hands on experience with PK/PD modeling and regulatory
guidelines
* hands on experience with tools such as WinNonLin, NONMEM, R, and
other relevant software
* Excellent written and verbal communication skills
* Ability to prioritize and multitask
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Brenda Roseberry
Vice President, Scientific Recruiting
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
315-415-4353 - Mobile
