Director/Sr. Director, clinical pharmacokinetics: (mixed role in clinical pharmacokinetics and pharmacometrics strategy) United States (northeast)
Please send questions or CV to: brosebe...@cartermackay.com<mailto:brosebe...@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 studies 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) properties 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 characterization strategies for compounds under drug development for global regulatory submission including eCTD dossiers 7. Provides expert scientific and strategic consultation to R&D and regulatory 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 which includes pharmacokinetics and a minimum of 10-years' experience analyzing preclinical and clinical pharmacology studies. Formal training and/or experience in pharmacometrics is a huge plus. * Expert understanding of the global drug dev. process and collaborations among multiple functions from discovery to commercialization. In-depth knowledge of the drug development process, GLP and GCP. * Innovate with PK/PD and pharmacometrics on strategic decisions at all phases of clinical dev. process * Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects * Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance) * Leads departmental training on scientific and process improvements [cid:1.1213385771@web31815.mail.mud.yahoo.com] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers, Bioanalysis 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [cid:image001.png@01CBC1F8.25033B10] <http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_>
