Highly experienced Project Director and Clinical Team Leader with over 30 years’ broad experience in the pharmaceutical industry; spanning both large pharma and small-medium enterprises (SMEs), leading development projects from discovery to lifecycle management in a variety of therapeutic areas.
After an early lab based career with SmithKline & French, worked for 20 years with GlaxoSmithKline seeing that organisation grow from modest beginnings as Glaxo Group Research into GlaxoWellcome, and then GSK, gaining broad experience in respiratory, GI and CNS therapy areas. Highlights including delivery of the migraine products, Imigran®, and Naraming® to the market in the 1990s, and helping embed the Psychiatry Centre of Excellence for Drug Discovery in the early years of GSK.
After a couple of years experiencing the varied life of an SME working as Clinical Development Director with an Anglo-Japanese pharmacogenomics life sciences company PGXIS, joined Norgine as Therapy Area Director in April 2011. Helped Norgine transition through a period of organisational change embedding a shift from line to matrix working. Currently heading the Clinical Development group, with personal responsibilities for line management, GCP, service provider selection and Sponsor oversight. The role also includes matrix management governance responsibilities for a variety of projects in gastroenterology, hepatology and critical care, with experience including medicinal products, medical devices, diagnostics and advanced therapeutic medicinal products (ATMPs). Recent highlight seeing PLENVU® gain both EU MAA & US NDA approvals & subsequent launches of the world’s first 1L bowel preparation in 2018.
Outside of work, my wife and 4 children are my most precious concerns, and as the children grow towards independence, tennis is a passion and golf an enigma, both yet to be conquered to any degree of satisfaction!
Amit Patel is currently an Associate Director at AastraZeneca, where he is responsible for the strategic alliance between AstraZeneca and Covance Central Laboratories into an industry pioneering operational model, to deliver central laboratory, bioanalysis and specialty testing for Astra Zeneca’s clinical portfolio. Amit has broad knowledge of the operational delivery of clinical programmes and understands the complexities surrounding, the sourcing and management of contract laboratories needed to deliver today’s complex clinical studies. With a background in academic science Amit understands the needs of the customer in the delivery of a quality sample for research needs.
Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.
Global Development Operations Process Improvement lead responsible for Clinical Study Start up and Informed consent processes in Amgen. As of Jan 2019 responsibilities expanded to study conduct and closeout processes.
Implementation lead for eConsent
Amgen representative to the TransCelerate Biopharma organization for eConsent.
Was Amgen Shared Investigator Platform (SIP) implementation lead and Amgen representative in TransCelerate SIP team during 2018.
Experience in training, process and quality roles and in line managing teams. Broad knowledge of drug development and the pharmaceutical industry.
