NONMEM Users Network Archive

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Bay area AD/Dir. role in Clinical Pharmacokinetics available

From: Brenda Roseberry <broseberry>
Date: Fri, 8 May 2020 18:12:55 +0000

New opportunity in the bay area of CA available. Full time opportunity with=
 an established client. Job description below. Please contact me at brosebe=
rry
This individual will be responsible for the dual development and implementa=
tion of both Clinical Pharmacology and Modeling and Simulation (M&S) strate=
gies in support of the company portfolio.
Professional Responsibilities:

  * Integrate PK, PD, safety, and efficacy data with M&S methodologies, s=
panning population (PopPK) to quantitative systems pharmacology (QSP) appro=
aches
  * Will support multiple quantitative clinical pharmacology deliverables=
, both with hands-on contributions and of work conducted by external vendor=
s
  * Provide both departmental representation and subject matter expertise=
 on development teams
  * Author and/or review documents including clinical protocols, M&S anal=
ysis 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 clin=
ical pharmacology issue
  * Supervise outsourced studies with external vendors
Education/Experience:

  * Ph.D. in Pharmacokinetics, Pharmacometrics, Engineering, Pharmaceutic=
al 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, c=
linical trial simulation, and/ or QSP modeling) to inform drug development
  * Excellent verbal and written communication skills and interpersonal s=
kills
  * 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





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Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax
   [linked logo] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msg=
ConversationId=6641167769234657280&msgOverlay=true>



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Received on Fri May 08 2020 - 14:12:55 EDT

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