Vice President, International Drug Development
- Integrated drug development strategy
- Data interpretation and positioning
- FDA and European Regulatory Agency interactions
- Clinical development
Catherine has extensive experience in international drug development gained through more than 20 years of working within the pharmaceutical industry. She holds a flexible skill set ranging from development strategy, operational execution, as well as leading and managing projects and teams.
Prior to joining BlueReg Pharma Consulting, Catherine was at Allergan Ltd where her most recent role was as a global drug development team leader. In this role Catherine lead cross-functional development teams (CMC, nonclinical, clinical, regulatory, and marketing) with responsibility for development programmes through to approval.
At Allergan Catherine has also had roles as the scientific and clinical strategy leader to development programmes at various stages of development. She has gained a considerable experience in a range of regulatory agency interactions and negotiations, particularly with the FDA and European agencies, as well as having a proven track record with successful submissions.
Prior roles at Allergan included being the Head of a Clinical Research Unit which had an in-house team of more than 40 people and a field based team of over 100 people. Catherine has also had clinical roles at Eisai Ltd and Schwartz Pharma Ltd, and following completion of her PhD had a position as a research fellow at King’s College Hospital, London.
During Catherine’s career to date she has been an author on more than 20 publications in international scientific journals.