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Director, Clinical Pharmacology
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$166,800 - $226,800 a year
Full-time
- She/He will provide clinical pharmacology and pharmacometric expertise for: characterizing pharmacokinetic profiles; dose selection justification; assessing drug/food interaction potential; characterizing QT prolongation potential, etc.
- This will be accomplished by implementing novel quantitative techniques and working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc.
- Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
- Qualifications: A Ph. D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least eight years of industry and/or related post- doctoral experience is preferred.
- Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential.
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