Member, Expert Committee on Clinical Trials (ECCT) - 13 Posts at Pharmacy and Poisons Board

JOB PURPOSE

The ECCT member shall provide timely, high-quality scientific advice to the Chief Executive Officer on all matters relating to clinical trials, in accordance with the Pharmacy and Poisons Act, the Clinical Trials (Conduct of Clinical Trials) Rules, 2022, and relevant guidelines

DUTIES AND RESPONSIBILITIES

• Providing expert recommendations to PPB on clinical trial protocols and study reports.
• Recommending regulatory actions, including approval, suspension, or halting of ongoing clinical trials.
• Advising on proposed amendments to approved clinical trial protocols.
• Reviewing findings from Good Clinical Practice (GCP) inspections of trial sites, CROs, and sponsors, and offering regulatory recommendations.
• Providing guidance on regional and international joint reviews of clinical trial applications.
• Periodically assessing Kenya’s clinical trials regulatory system and recommending improvements.
• Advising on the development or revision of clinical trial guidelines and legislation, in alignment with WHO standards and GCP requirements.
• Offering expert input on all matters related to the regulation of clinical trials in Kenya.
• Contributing to the development, maintenance, and enhancement of the Kenya Clinical Trials Registry.
• Undertaking any other functions necessary to support the objectives and mandate of the Committee.

REQUIRED QUALIFICATIONS

• Have a Master’s Degree in Pharmacy, Medicine, or any health-related field from a recognized university. Relevant areas include (but are not limited to): Pharmacovigilance, Pharmacoepidemiology, Pharmacology/Clinical Pharmacology, Toxicology/Clinical Toxicology, Pharmacotherapeutics, Drug Development, Clinical Trials, Genetics, Biotechnology, Biostatistics/Medical Statistics, Non-Communicable Diseases, Immunology, Medical Devices, Clinical Pharmacy, Paediatrics, Obstetrics and Gynaecology, Epidemiology, Pathology, Internal Medicine, Vaccinology, Tropical and Infectious Diseases, Neglected Tropical Diseases, Oncology, Cardiology, Cosmetology, Biomedical Technology.
• Preference will be given to applicants with a PhD in any of the above fields.
• At least five (5) years of relevant experience in safety and risk assessment within their area of expertise.
• Prior experience in the design, conduct, or monitoring of clinical trials will be an added advantage.
• Be registered with a relevant Professional body and, possess valid practicing license where applicable;
• Proficiency in computer applications; and
• Fulfill the requirements of Chapter Six (6) of the Constitution.