Director/Sr. Director, clinical pharmacokinetics: (mixed role in clinical
pharmacokinetics and pharmacometrics strategy) United States (northeast)
Please send questions or CV to:
[email protected]<mailto:[email protected]> 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:[email protected]]
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:[email protected]]
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