Donna S Cox

Background

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.