Consultant Profile: Kathryn Lee PhD, MICR

Kathryn Lee is an experienced clinical research professional having held positions as a Clinical Research Associate, Project Manager and Compliance Manager working on phase II through IV clinical trials in a range of therapeutic areas. Kathryn has experience within both CRO and global pharmaceutical company environments. She is results-focussed, with excellent problem solving and communication skills, and a creative team leader, effectively motivating others to success.

Experience Summary

Compliance Management:

Provided GCP guidance and compliance support to Global Clinical Operations; supporting R&D audits and regulatory authority inspections; using clinical trial and project management expertise to provide input into Standard Operating Procedure review and process improvement programmes.

Project Management:

Managed a programme of 11 phase 2 & 3 clinical trials for a paediatric influenza nasal-spray vaccine. Team-leader, supervising and mentoring a team of 5-8 Project Managers based in UK and Belgium in addition to CRO / service provider management.

International Project Manager of a phase II monoclonal antibody trial in Chronic Lymphocytic Leukaemia. Responsible for managing set-up and initial recruitment activities for eleven countries.

Global Project Manager for an Expanded Access Programme (EAP) of an EGFR-TK inhibitor in Non-Small Cell Lung Carcinoma, with over 35,000 participants at 3,250 clinical sites in 76 countries.

CRA monitoring a phase 2 study of a monoclonal antibody for renal cell carcinoma and prostate cancer.

Multiple sclerosis (Project Manager, phase 3b)
Osteoporosis (Project Manager, phase 3b)
Oncology (CRA, phase 2)
Dermatology (Lead CRA, phase 3 )
Stroke (CRA, phase 3)
Hepatitis B (CRA, phase 2)
Blood Substitutes/High Risk Surgery (Lead CRA, phase 2)

In addition to her industry experience in oncology, Kathryn holds a PhD from the University of Sheffield and has held Post-Doctoral Positions at the University of Manchester and the Institute for Cancer Research, Royal Marsden Hospital as a Molecular Biologist conducting laboratory-based research in a range of cancers.