Stephen Kirk
Consultant / Director
About
Experienced regulatory toxicologist with almost 30 years experience of working in the drug development industry particularly with EMA, UK and FDA regulatory procedures and pathways. Over 20 years of GLP experience gained working in a variety of nonclinical CRO's (across North America and the UK). A wide range of experience in the nonclinical development of many classes of therapeutics including NCE's, vaccines, biotherapeutics, cell therapies, gene therapies and radiopharmaceuticals. Specialist in biopharmaceutical and immunomodulatory therapeutics.
United Kingdom
Knaresborough
Pharmaceuticals
Immunotoxicology, Assay Development, Assay Validation, ICH Guidance, In vivo safety, Working and Master Cell Banks, MHRA, EMA, Business Strategy, Business Development, Budget Management, Planning Budgeting & Forecasting, Safety Pharmacology, PIP, Gap Analysis, CRO Selection, Module 2 eCTD, Orphan Drugs, U.S. Food and Drug Administration (FDA), Cancer Research
Experience
Consultant / Director
Stephen Kirk Nonclinical Drug Development Services Ltd
Knaresborough, England, United Kingdom
Independent Toxicology Consultant
Principal Consultant
Scendea
Bishop’s Stortford, England, United Kingdom
Head of Non-Clinical Science
Allergy Therapeutics
United Kingdom
Senior Toxicology Manager
KalVista Pharmaceuticals, Inc.
Salisbury, United Kingdom
Principal Investigator
Covance
Harrogate, United Kingdom
Global lead, Immunotoxicology
Covance
Responsible for oversight of Immunotoxiclogy services at Covance preclinical sites across globe. Identify budget needs and areas of potential growth and development.
Immunotoxicology specialist.
Covance.
Day to day duties include having an overarching view of all aspects of acquisition, analysis, reporting and interpretation of immunotoxicology data. Responsible for establishing and maintaining the highest level of quality in data capture and interpretation and reporting, and providing advice and support to external and internal customers involved with immunotoxicology.
Study Director, Toxicology
Aptuit
Study Director
Bio-Reliance
Senior Research Scientist
Charles River, Montreal
Montreal, Canada Area
Education
University of Leeds
Biopharmaceutical Development
The Open University
Business Studies
University of Glasgow
Immunology
University of Glasgow
Immunology
Stephen Kirk's Contact Information
Phone
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