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Experienced Director Global Regulatory Affairs with a demonstrated history of working in the pharmaceuticals industry. Skilled in Neurotoxins, CMC, Medical Devices, Clinical Data Management, Biotechnology, U.S. Food and Drug Administration (FDA), Global Agencies, and Research and Development (R&D). Strong business development professional with a Doctor of Philosophy - PhD focused in Biostatistics from University of Southern California.
Telix Pharmaceuticals Limited
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Senior Vice President, Global Regulatory AffairsTelix Pharmaceuticals Limited Jun 2024 - PresentNorth Melbourne, Victoria, Au
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Executive Director, Regulatory Affairs CmcAbbvie May 2020 - Jun 2024North Chicago, Illinois, Us -
Executive Director, Global Regulatory Affairs Cmc - BiologicsAllergan Aug 2016 - May 2020Dublin, Coolock, IeLead team of Regulatory CMC professionals supporting the global strategies for both development-stage as well as lifecycle management of commercialized biologics products (including BOTOX). Regulatory Affair's appointed Select Agent and Data Protection Management Officer. Additionally, the team leader for a global neurotoxin development project overseeing clinical, commercial, CMC/GPT, device, non-clinical and regulatory sub-teams. -
Director, Global Regulatory Affairs Cmc - Manufacturing OperationsAllergan Sep 2013 - Aug 2016Dublin, Coolock, IeLead team of RA-CMC personnel across Allergan's global manufacturing sites.Coordination with QA for change control activities for both development and commercial products.Supporting both small molecule and biologics products.
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Director, Global Regulatory Affairs Cmc - Biologics Lifecycle ManagementAllergan Feb 2012 - Sep 2013Dublin, Coolock, IeLead team supporting global lifecycle management for BOTOX
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Senior Manager, Global Regulatory Affairs - CmcAllergan 2009 - Feb 2012Dublin, Coolock, IeGlobal RA-CMC lead for BOTOX Cell-based assay as well as BOTOX 200U registrations.Global RA-CMC lead for numerous small-molecule products including Lumigan, LATISSE and ACZONE families.
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Senior Manager, BiostatisticsAllergan 2007 - 2009Dublin, Coolock, IeManagement of non-clinical statistical research team including direct responsibility for the botulinum toxin programs. Statistical support of several departments including drug discovery and drug safety as well as global technical operations and had a key role in bioassay development and validation efforts within these areas.
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Manager, BiostatisticsAllergan 2005 - 2006Dublin, Coolock, IeStatistical Lead for BOTOX Post-approval/Life-cycle Management Team.Lead author of CTD documentation for stability sections.Support of initial filings for additional product presentations (50U/200U)Design and validation of refinement of potency assay.Research and development of alternative potency assays.Initial contact and presentation to EDQM and ICVAAM regarding alternatives to potency testing.Competitive analysis.
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Principal BiostatisticianAllergan 2003 - 2005Dublin, Coolock, IeCollaboration and presentations to NIBSC and Ph Eur working group regarding draft EU monograph's requirements for potency assays for botulinum toxins. Design, validation and regulatory submission authoring for updated calculations to meet EP monograph requirements for botulinum toxins. Development and validation of associated potency software application.Strategy development and agency presentations around reference standard program for BOTOX.Author statistical analysis plan for comparability of alternate manufacturing site for BOTOX drug substance.
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Senior BiostatisticianAllergan 2001 - 2003Dublin, Coolock, IeFirst non-clinical statistician hired in support of BOTOX. Statistical lead in support of re-validation of potency assay and selection of non-HSA formulation selection for BOTOX. Statistical support of initial development for for alternative potency assays for BOTOX.
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International Chair Umpire And Referee (Itf/Atp/Wta Tennis Tours)Tennis 1995 - 2004Us -
BiostatisticianCity Of Hope 1995 - 1999Duarte, Ca, UsManager of Biostatistics Core for two NIH-funded grants on "Bioengieneered Antibodies in Cancer Imaging and Therapy" Program Project. Early-phase adaptive clinical trial designs. Compartmental and survival analysis.
Kenneth Clarke Skills
Kenneth Clarke Education Details
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University Of Southern CaliforniaBiostatistics -
University Of TorontoPure Mathematics
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Western UniversityPure Mathematics
Frequently Asked Questions about Kenneth Clarke
What company does Kenneth Clarke work for?
Kenneth Clarke works for Telix Pharmaceuticals Limited
What is Kenneth Clarke's role at the current company?
Kenneth Clarke's current role is Senior Vice President, Head of Global Regulatory Affairs at Telix Pharmaceuticals.
What is Kenneth Clarke's email address?
Kenneth Clarke's email address is cl****@****gan.com
What is Kenneth Clarke's direct phone number?
Kenneth Clarke's direct phone number is (800) 377*****
What schools did Kenneth Clarke attend?
Kenneth Clarke attended University Of Southern California, University Of Toronto, Western University.
What are some of Kenneth Clarke's interests?
Kenneth Clarke has interest in Children, Aviation, Photography, Surfing, Tennis, Travel, Wine.
What skills is Kenneth Clarke known for?
Kenneth Clarke has skills like Regulatory Affairs, Pharmaceutical Industry, Statistics, Biotechnology, Sas, Clinical Trials, Biostatistics, Data Analysis, Fda, Validation, Clinical Development, Life Sciences.
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