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[NMusers] PK job available!

From: Brenda Roseberry <broseberry_at_cartermackay.com>
Date: Mon, 17 Jul 2017 17:44:51 +0000


Director/Sr. Director, clinical pharmacokinetics: (mixed role in clinical p=
harmacokinetics and pharmacometrics strategy) United States (northeast)

Please send questions or CV to: broseberry_at_cartermackay.com<mailto:broseber=
ry_at_cartermackay.com> phone: 315-415-4353

1. Supervise PK data analysis and interpretation with appropriate tools
2. Strategize PK and PK/PD investigations in Phase I, II, III and IV studie=
s as well as srategize meta-analysis of population PK and PK/PD data
3. Manage CROs to conduct meta-analysis and report PK and PK/PD data
4. Evaluate the relationship between exposure and pharmacodynamic (PD) prop=
erties for compounds 5rom discovery to proof of activity through late stage=
 Phase 3 development
6. Set PK and PK/PD strategies and overall clinical pharmacology characteri=
zation strategies for compounds under drug development for global regulator=
y submission including eCTD dossiers
7. Provides expert scientific and strategic consultation to R&D and regulat=
ory for multiple projects across multiple therapeutic areas
8. people management

Skills/Knowledge Required:
* Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline w=
hich includes pharmacokinetics and a minimum of 10-years' experience analyz=
ing preclinical and clinical pharmacology studies. Formal training and/or e=
xperience in pharmacometrics is a huge plus.
* Expert understanding of the global drug dev. process and collaborations a=
mong multiple functions from discovery to commercialization. In-depth knowl=
edge of the drug development process, GLP and GCP.
* Innovate with PK/PD and pharmacometrics on strategic decisions at all pha=
ses of clinical dev. process
* Interacts effectively with managers from various disciplines; serves as e=
xpert and internal consultant on assigned area and liaises with partners on=
 projects
* Negotiates with other functional areas on project outcomes and deliverabl=
es to meet conflicting demands (time, cost, quality/ performance)
* Leads departmental training on scientific and process improvements




[cid:1.1213385771_at_web31815.mail.mud.yahoo.com]
  Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers, Bio=
analysis
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax
   [cid:image001.png_at_01CBC1F8.25033B10] <http://www.linkedin.com/profile/vi=
ew?id=19937880&authType=name&authToken=b5d_>






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Received on Mon Jul 17 2017 - 13:44:51 EDT

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