Gerald Klein, MD


  • 40+ years as successful C-suite pharma executive, Chief Medical Officer, and board member of large and small companies, with global experience ranging from preclinical development of biologics, devices, diagnostics, and drugs, to post-marketing studies.
  • 2017-Present: BOD to Plakous Therapeutics
  • 2016-Present: CMO to ArunA Biomedical
  • 2015-Present: Principal, MedSurgPI, LLC
  • 2011-2015: President and CEO, Entera Health, Inc.
  • 2010-2011: Chief Medical Officer, Oxygen Biotherapeutics
  • 2010-2011: Consulting Chief Medical Officer, Talecris Biotherapeutics/Grifols
  • 2005-2010: Chief Medical Officer/ VP, Global Medical and Clinical Affairs, Talecris Biotherapeutics
  • 2003-2005: Vice President of Medical Affairs, Clinical Research, and Safety, Dey/Merck KGaA
  • 2003-2005: North Bay Allergy and Asthma Associates
  • 2001-2003: Vice President of Clinical Trials, Specialty Laboratories
  • 1999-2001: Executive Vice President, Clinical Development and Medical Affairs, Clingenix, Inc.
  • 1995-1999: Sr. Vice President/Executive Director, Infectious Allergy/Respiratory Disease, Quintiles Transnational
  • 1988-1995: Founder/CEO/President, San Diego Clinical Research Associates, a CRO acquired by Quintiles

CMO/Executive Management; Drug Development and Commercialization; BLAs, NDAs, and International Approvals; Program Creation; Clinical Trials Development and Management; Proof-of-Concept Studies; Pharmacovigilance Programs; FDA Interactions; Medical/Clinical Affairs; FDA/Medicaid Presentations; Bid Defense; Board Membership; Academia; Scientific Advisor; Technology Evaluation; and Teambuilding.
Clinical Research/Development Therapeutic Areas: Pediatrics, Respiratory, Allergy/Asthma, Dermatology, Immunology, Rheumatology, Pulmonary, Oncology, Gastroenterology/IBS, and Depression.
MD – University of Brussels Medical School, Belgium; Residency – New Jersey College of Medicine; Fellowship – University of California, Irvine College of Medicine (Allergy/Immunology); Board-certified in Pediatrics and in Allergy and Clinical Immunology. Served 15 years in academia. Has 122 industrial research projects, 105 presentations, 58 publications, 27 advisory boards, 22 patient education resources, 13 abstracts, nine blogs, and three books/chapters.

  • BLA, NDAs, and international approvals: Chronic Idiopathic Demyelinating Polyneuropathy, COPD, Acute
  • Infectious Sinusitis, Pediatric Idiopathic Chronic Urticaria; conducted MS and stroke clinical trials and developed program for Myasthenia Gravis.
  • Originated and successfully developed proof-of-concept Phase 2 study demonstrating efficacy of Cipro in treatment of sinusitis, leading to a successful program and worldwide approval for this additional indication.
  • Created international pharmacovigilance program resulting in the removal of major regulatory product concern from FDA and Health Canada.
  • Helped create complicated preclinical stroke, respiratory, and deep vein thrombosis programs.
  • Resolved a FDA data integrity problem which threatened to stop a drug development program.
  • Built dynamic medical affairs teams that bolstered commercial activity, including having the Presidents of the American Gastroenterology Association (Mayo Clinic) and the American College of Gastroenterology (Northwestern) conduct IITs studies for us.
  • Developed a medical affairs team and program that won the approval of most state legislatures to allow the self-administration of an auto-injector of epinephrine in the classrooms.
  • Experience in a large and small, public and private CROs and biopharmaceutical companies.
  • Assisted in the successful bid defense of numerous CRO projects.
  • Developed a medical affairs team and program that won the approval of most state legislatures to allow self-administration of an auto-injector of epinephrine in classrooms.
  • Assisted in the successful bid defense of numerous CRO projects.


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