I have 12 years clinical development experience in both pharmaceutical, biotech and CRO companies, specialising in oncology and haematology. Previous roles include Preclinical Supervisor, Clinical Research Associate, Global Project Manager and Clinical Development Advisor.
As research is focusing on cellular processes to determine causal factors in the aetiology of diseases, my cell and molecular biology degree enables me to provide scientific information appropriate for all levels of understanding.
I have in depth knowledge of drug development requirements from preclinical to phase 1 transition, including regulatory requirements, exploratory/proof of concept studies, pivotal registration studies and post marketing surveillance/phase IV programs.
Prior to setting up Egerton Clinical Consulting, I spent five years as the Novartis Oncology UK Clinical Advisor for the development, launch and post marketing activities of the first signal transduction inhibitor (Glivec, imatinib). In this role I bridged clinical and marketing groups during product launch and post marketing activities, and was responsible for Key Opinion Leader development, set up of named patient supplies, providing educational lectures, processing medical information queries, liaison with cancer networks and extensive medical writing. I have prepared pharmacoeconomic submissions, product monographs, slide kits and training materials, article reviews, treatment guidelines and information for NHS drug pharmacists. Medical writing has been an integral part of my job within the industry over the last 12 years.
I have ten years experience of project management, including many pivotal global studies with budget responsibility, development and tracking of project management plans and quality assurance responsibility. I have project managed and monitored phase I to IV studies, and responsibilities have included study design, chairing advisory boards to review clinical development plans with physicians, writing protocols and patient information sheets, preparing ethical submissions, training for CRAs and study centres, chairing investigator meetings, writing clinical study reports and publications.
I have also provided training programs for cross functional teams, including full therapeutic and drug training to clinical, healthcare and sales teams, and ICH-GCP/SOP training for clinical departments.
Since setting up Egerton Clinical Consulting Ltd, I have been contracted to write pharmacoeconomic submissions, provide training manuals (both therapeutic and ICH/GCP procedures for clinical trials), sales materials (including detail aids and slide kits), National guidelines, COREC submissions (including patient information sheets), clinical study reports, publications, act as facilitator and medical writer for advisory board meetings and provide project management services for clinical programmes (including consulting on clinical development plans).