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This profile was last updated on 8/22/13  and contains information from public web pages and contributions from the ZoomInfo community.

Dr. Malcolm J. McKay Ph.D.

Wrong Dr. Malcolm J. McKay Ph.D.?
 
Background

Employment History

Education

  • Ph.D. , biochemistry
    University of London
  • B.S. , biology
    University of Portsmouth
  • M.D.
22 Total References
Web References
Management Team
www.vivus.com, 29 June 2013 [cached]
Malcolm McKay, Ph.D.
Vice President, Regulatory Affairs
Dr. McKay has served as the company's Vice President, Regulatory Affairs since June 2010. Dr. McKay has over 25 years of compliance experience covering all aspects of pharmaceutical drug development and commercialization. Prior to joining the company, Dr. McKay was self-employed as a Pharmaceutical Development and Compliance Consultant. Dr. McKay previously served as the Vice President Corporate Compliance with InterMune, Inc. from 2003 to 2007, the Vice President of Quality and Regulatory Affairs with Cell Genesys from 2000 to 2003 and was Vice President Regulatory Affairs with Celtrix Pharmaceuticals from1996 to 2000. Dr. McKay has a PhD in Biochemistry from University of London.
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Malcolm McKay Ph.D.
Todays News
www.prnewswire.com, 7 Nov 2000 [cached]
FOSTER CITY, Calif., Nov. 7 /PRNewswire / -- Cell Genesys, Inc. (Nasdaq : CEGE) today announced that Malcolm J. McKay, Ph.D. has joined the company in the new position of vice president, quality and regulatory affairs.Dr. McKay, who brings over sixteen years of regulatory affairs, quality control and product development experience to Cell Genesys, served most recently as vice president, regulatory affairs at Celtrix Pharmaceuticals, a company which was recently acquired by Insmed, Inc.
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Dr. McKay, 44, previously with Celtrix Pharmaceuticals, has also held various management positions in the regulatory affairs and quality assurance areas with other biotechnology companies including COR Therapeutics, Berlex Biosciences and Triton Biosciences.Dr. McKay holds a Ph.D. in biochemistry from the University of London and a B.S. in biology from the University of Portsmouth in Hampshire, UK.
Dr. McKay will be assuming the management of the regulatory affairs function from Dale G. Ando, M.D., vice president of clinical research, who will now focus on the management of the company's rapidly expanding clinical trial programs.Cell Genesys currently has three GVAX (R) cancer vaccine clinical trials under way and expects to launch multiple additional trials for GVAX (R) cancer vaccines and hemophilia gene therapy during the next year.
InterMune Investor Relations
www.corporate-ir.net, 13 May 2003 [cached]
BRISBANE, Calif., May 13, 2003 /PRNewswire-FirstCall via COMTEX/ -- InterMune, Inc. (Nasdaq: ITMN) announced today that it has hired Fred J. Schreiber as the Company's new Senior Vice President of Human Resources, and Malcolm McKay, Ph.D., to the newly created position of Vice President of Corporate Compliance.
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As Vice President of Corporate Compliance, Dr. Malcolm McKay will be responsible for expanding InterMune's Corporate Compliance department and maintaining InterMune's high regulatory standards, including good clinical practices (GCP), current good manufacturing practices (cGMP) and good laboratory practices (GLP). Dr. McKay will report to Dr. Marianne Armstrong, InterMune's Senior Vice President of Global Regulatory Operations and Corporate Compliance.
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Dr. McKay brings more than 17 years of biopharmaceutical industry experience in the areas of compliance, regulatory, quality assurance and process development to InterMune. Most recently, Dr. McKay was Vice President of Regulatory Affairs at Cell Genesys, where he was responsible for regulatory and quality assurance. Prior to Cell Genesys, Dr. McKay held senior management positions at Celtrix Pharmaceuticals, COR Therapeutics (now Millennium) and Berlex Biosciences. Earlier in his career, he worked at Triton Biosciences and Abbott Laboratories. Dr. McKay holds a Ph.D. in Biochemistry from the University of London and completed his post-doctoral training at the Medical College of Virginia.
Cell Genesys (Nasdaq: CEGE) - News Release
phx.corporate-ir.net [cached]
Cell Genesys Elects Malcolm McKay Vice President of Quality and Regulatory Affairs
FOSTER CITY, Calif., Nov. 7 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today announced that Malcolm J. McKay, Ph.D. has joined the company in the new position of vice president, quality and regulatory affairs.Dr. McKay, who brings over sixteen years of regulatory affairs, quality control and product development experience to Cell Genesys, served most recently as vice president, regulatory affairs at Celtrix Pharmaceuticals, a company which was recently acquired by Insmed, Inc.
"We are very pleased to have Malcolm join our management team," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys.
...
Dr. McKay, 44, previously with Celtrix Pharmaceuticals, has also held various management positions in the regulatory affairs and quality assurance areas with other biotechnology companies including COR Therapeutics, Berlex Biosciences and Triton Biosciences.Dr. McKay holds a Ph.D. in biochemistry from the University of London and a B.S. in biology from the University of Portsmouth in Hampshire, UK.
Dr. McKay will be assuming the management of the regulatory affairs function from Dale G. Ando, M.D., vice president of clinical research, who will now focus on the management of the company's rapidly expanding clinical trial programs.
Management Team
www.vivus.com, 29 June 2013 [cached]
Malcolm McKay Ph.D.
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