Mwango Kashoki, MD, MPH, is the Vice President—Regulatory Affairs within Parexel International’s Regulatory Consulting Services group. Dr. Kashoki brings over 16 years of U.S. Food and Drug Administration (FDA) regulatory experience to this role, in which she advises pharmaceutical companies on the formulation of development plans and regulatory strategies across all phases of clinical development and in multiple therapeutic areas. As a member of the RCS senior leadership team, she develops and executes the organization’s regulatory business strategy, and leads a global team of Vice Presidents who also assist companies with formulate clinical development plans and regulatory strategies.
Prior to joining Parexel, Dr. Kashoki was the Associate Director for Safety in the FDA’s Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER). In this position, she developed and had oversight over the full span of postmarket drug safety policies and procedures in OND, as well as OND’s activities in the FDA’s Safety First and Sentinel Initiatives. She also served as a Senior Advisor to the OND Director and review divisions on complex and broad drug safety issues and strategic initiatives. Notable accomplishments include co-authorship of multiple FDA safety-related guidances and reports to Congress on FDA’s drug safety programs, representing OND on the FDA Drug Safety Board, and participating as an FDA representative during the Prescription Drug User Fee Act V (PDUFA V) safety-related negotiations between FDA and the pharmaceutical industry.
Dr. Kashoki joined FDA in 2002 as a primary medical officer in in the OND’s former Division of Anesthesia, Analgesia and Rheumatology Products. She then served as clinical team leader, managing a team of physician primary medical officers. Subsequently, Dr. Kashoki was the Associate Director for Special Projects, managing the development and conduct of research projects under FDA's Critical Path Initiative and in collaboration with external groups.
Since joining Parexel, Dr. Kashoki was selected to participate in the Women in Leadership (WiL) program, which is organized through Linkage and Menttium and is aimed at accelerating the development of women leaders. She has participated as a speaker in Parexel’s Wisdom Circles, in which small teams are mentored by senior leaders on topics such as leadership, communication, financial, and business acumen. She is also a member of Parexel’s Diversity, Equity and Inclusion Executive Committee, which is comprised of senior and corporate leaders within Parexel. She is the Executive Sponsor of Parexel’s Black Employees Advisory Consortium (BEACON), a steering committee that works to influence recruitment and development of Black employees, as well as support inclusion of Black patients in clinical research. In March 2021, she was named a Luminary by the Healthcare Businesswomen’s Association (HBA) for her contributions to finding solutions to increase diversity in clinical trials and mentorship of others to advance their healthcare careers.