Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000 employees
Founded 1961
Director, Clinical Pharmacology - Pharmacometrics
November 12
Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000 employees
Founded 1961
Description
• Develop and execute clinical pharmacology and pharmacometrics strategies for novel drugs. • Provide expertise in characterizing pharmacokinetic profiles and dose selection justification. • Plan and review study designs & analysis plans; analyze & interpret data. • Author and defend clinical pharmacology sections of regulatory filings. • Manage clinical pharmacology vendors, and consultants for specific project needs.
Requirements
• Bachelors with 10+ years of experience or Masters with 7+ years of experience required. • A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline preferred. • Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications essential. • Familiarity with DMPK studies, bioanalytical methods preferred. • Prior experience in oncology drug development preferred. • Hands-on experience in performing NCA using Phoenix WinNonlin essential. • Experience with NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus preferred.
Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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