New opportunity in the bay area of CA available. Full time opportunity with an
established client. Job description below. Please contact me at
[email protected]<mailto:[email protected]> for more info:
This individual will be responsible for the dual development and implementation
of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in
support of the company portfolio.
Professional Responsibilities:
* Integrate PK, PD, safety, and efficacy data with M&S methodologies,
spanning population (PopPK) to quantitative systems pharmacology (QSP)
approaches
* Will support multiple quantitative clinical pharmacology deliverables,
both with hands-on contributions and of work conducted by external vendors
* Provide both departmental representation and subject matter expertise on
development teams
* Author and/or review documents including clinical protocols, M&S analysis
plans and reports as well as study reports, regulatory documents, and journal
articles
* Attend and present at internal and external meetings as needed
* Support interactions with worldwide Health Authorities regarding clinical
pharmacology issue
* Supervise outsourced studies with external vendors
Education/Experience:
* Ph.D. in Pharmacokinetics, Pharmacometrics, Engineering, Pharmaceutical
Sciences, or related discipline
* 5+ years (10+ for director position) of industry, regulatory, and/or
related post-doctoral quantitative clinical pharmacology experience
Professional Requirements:
* Demonstrated experience with leveraging M&S approaches (e.g. PopPK,
clinical trial simulation, and/ or QSP modeling) to inform drug development
* Excellent verbal and written communication skills and interpersonal skills
* Strong leadership and project management skills
* Hands-on experience with M&S software (e.g. NONMEM, R, MATLAB, and/or
SimBiology)
* Regulatory filing experience is highly desirable
[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
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