Dr. Malone has extensive research and development experience in the areas of pre-clinical discovery research, clinical trials, vaccines, gene therapy, bio-defense, and immunology. He has over twenty years of management and leadership experience in academia, pharmaceutical and biotechnology industries, as well as in governmental and non-governmental organizations.

Dr. Malone specializes in clinical research, medical affairs, regulatory affairs, project management, proposal management (large grants and contracts), vaccines and biodefense. This includes writing, developing, reviewing and managing vaccine, bio-threat and biologics clinical trials and clinical development strategies. He has been involved in developing, designing, and providing oversight of approximately forty phase 1 clinical trials and twenty phase 2 clinical trials, as well as five phase 3 clinical trials. He has served as medical director/medical monitor on approximately forty phase 1 clinical trials, and on twenty phase 2 clinical trials, including those run at vaccine-focused Clinical Research Organizations. His proposal development work has yielded clients billions of dollars.

Scientifically trained at U.C. Davis, U.C. San Diego, and at the Salk Institute Molecular Biology and Virology laboratories, Dr. Malone is an internationally recognized scientist (virology, immunology, molecular biology) and is known as one of the original inventors of mRNA vaccination and DNA Vaccination. His discoveries in mRNA non viral delivery systems are considered the key to the current COVID-19 vaccine strategies. Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines.

Dr. Malone has close to 100 peer-reviewed publications and published abstracts and has over 11,477 citations of his peer reviewed publications, as verified by Google Scholar. His Google Scholar ranking is “outstanding” for impact factors. He has been an invited speaker at over 50 conferences, has chaired numerous conferences and he has sat on or served as chairperson on numerous NIAID and DoD study sections.

A Fellow of the Royal Society of Medicine, he is the CEO and Principal Consultant of R.W. Malone M.D., LLC; and he has also served as Chief Medical Officer of Alchem Laboratories; CEO and Co-founder of Atheric Pharmaceutical, LLC; Adjunct Associate Professor at Kennesaw State University; Medical Director of Vaccines at Beardsworth Consulting Group, Inc.; Director of Clinical Development & Medical Affairs for Influenza at Solvay Pharmaceuticals, Inc. (currently Abbvie); Senior Medical Director at Summit Drug Development Services; Director of Business Development and Program Management at AERAS Global TB Vaccine Foundation; Associate Director of Clinical Research at Dynport Vaccine Company, LLC; Co-Founder and CSO of Intradigm, Corp.; Assistant Professor of Pathology at the University of Maryland's Baltimore School of Medicine; and Assistant Professor of Pathology at the University of California at Davis.