Donna S Cox
Dedicated Senior Director with 25 years of drug development experience on both small molecules and biologics (Phase 1-Phase 4). Led biosimilars team and Paxlovid clinical pharmacology team in submission of EUA/NDA.
- Role
- Senior Director Global Clinical Pharmacology at Astellas Pharma
- Location
- Norristown, PA, US
- LinkedIn followers
- 500 followers
About Donna S Cox
Dedicated and resourceful Clinical Pharmacology professional with over 20 years of experience across many therapeutic areas (antivirals, respiratory, cardiovascular, oncology, rare disease). Experience in Phase 1 through Phase 4 development on small molecules and biologics. Mangement experience in directing 3-4 reports. Experience in regulatory writing (2.7.2 and 2.7.1) and submissions (4-5 NDAs, EMAs, PMDAs etc.). Recent experience leading Paxlovid clinical pharmacology team for EUA and NDA and ROW submissions. Awarded Saxton award for Paxlovid by Pfizer. Additionally led biosimilars team. Proven record of success establishing collaborative relationships with internal and external personnel at all organizational levels while managing multiple clinical pharmacology issues. Recognized as a reliable team leader and team member who is self-motivated, results driven, adaptable and innovative; committed to maintaining a high-quality work product in a timely manner without sacrificing compliance and regulatory requirements. Committed to continuous improvement and developing my career.
Experience
Senior Director Global Clinical Pharmacology
Mar 2024 — Present · IL, US
Education
University of Maryland Baltimore
PhD, Pharmaceutical Sciences; Biopharmceutics and Pharmacokinetics
1996 — 2000
The Johns Hopkins University
Master of Science - MS, Anatomy
1994 — 1996
McDaniel College
Bachelor of Arts - BA, Biology/Biological Sciences, General
1980 — 1985
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