Director, Clinical Pharmacology - Pharmacometrics

September 21

Apply Now

Receive Emails with Similar Jobs

Business Wire

WebsiteLinkedInAll Job Openings

Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000

Description

• Develop and execute clinical pharmacology and pharmacometrics strategies for novel small molecules and biologics. • Provide pharmacology and pharmacometric expertise for characterizing pharmacokinetic profiles and dose selection. • Implement quantitative techniques and collaborate with functions like Clinical Development and Regulatory. • Plan and review study designs & analysis plans; author and defend clinical pharmacology sections of regulatory filings. • Analyze and present data to internal project teams and health authorities. • Manage clinical pharmacology vendors and mentor junior group members.

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 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. • Familiarity with DMPK studies, bioanalytical methods is preferred. • Prior experience in oncology drug development is preferred. • Hands-on experience in performing NCA using Phoenix WinNonlin is essential. • Experience with one or more of the following is preferred: NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus.

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness