Senior Medical Officer, Vaccine Development Global Program
PATH is an international nonprofit organization that transforms global health through innovation. We take an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential.
The mission of PATH's Vaccine Development Global Program (VAC) is to improve the health of populations, especially infants and children living in low-income countries, by accelerating development of vaccines that will be effective and affordable in the countries that most urgently need them. The program works with commercial partners, such as vaccine manufacturers and biotechnology firms, and nonprofit partners, such as universities and research institutions, from initial discovery through clinical trials to shorten the timeline for developing vaccines.
The Senior Medical Officer will be responsible for a range of clinical research activities within the Vaccine Development Global Program at PATH, assuming lead roles in setting up and implementing clinical development plans for various childhood vaccine candidates, and advising the Senior leadership in the development and implementation of sound ethical, scientific and regulatory strategies spanning the various PATH vaccines efforts.
The Senior Medical Officer will report to the Director of the Clinical and Regulatory Office at PATH’s Vaccine Development Global Program. Specific responsibilities include:
- Provides leadership and medical expertise in the planning, implementation and oversight of VAC-supported vaccine clinical trials and related activities for multiple vaccine candidates, including preparatory studies, phase I-IV clinical trials, and pharmacovigilance.
- Advises the PATH Senior Management group on the development of appropriate long-term, far-reaching ethical, scientific and regulatory strategies and approaches to facilitate the development of childhood vaccines and overcome obstacles that might impede/slow down VAC’s clinical trials agenda.
- Interprets data from preclinical studies and vaccine trials to determine the safety, immunogenicity and efficacy of vaccine interventions being evaluated; reviews adverse vaccine reaction reports; and investigates and assesses reports of severe adverse events. Makes medical judgment about causality for submission to the Food and Drug Administration (FDA), determines the implications for current and planned research and initiates necessary actions.
- For international trials, maintains cognizance and recommends approaches to resolve far-reaching or controversial situations concerning ethical issues and regulatory requirements involving patient populations, study risks and efficacy indicators.
- Advices the organization on the development of a long-term strategic vision to effectively fulfill the VAC research agenda. Along with the VAC leadership, determines and pursues essential courses of action to fulfill the VAC clinical trials agenda.
- Develops and promotes policies, instruments and procedures to support consistence and harmonization across VAC’s clinical trials.
- Serves as focal point for ethical reviews of all vaccine trials within VAC-PATH. Initiates, coordinates, and responds to Institutional Review Board and Institutional Ethics Committee submissions.
- Monitors clinical trial progress, relevance and risks and troubleshoots issues. Determines the need for and/or makes site visits to plan and evaluate on site clinical trial efforts; initiates appropriate action when research progress is inadequate. Makes recommendations regarding funding.
- Facilitates communication and collaborative efforts with all PATH Vaccine Development partners, collaborators and funders, including industry, academy, government agencies and non-governmental organizations.
- Represents PATH in interactions with the biotechnology/ pharmaceutical industry and the academic community such as to develop plans for testing agents, particularly with regard to study design, feasibility and relative priority, or in other high-level interactions with the private or public sector.
- Serves as a senior medical/scientific liaison with other PATH clinical scientists and with scientific and other professional staff representing FDA, World Health Organization (WHO), or other US or international agencies or nongovernment organizations including representing VAC in negotiations with the FDA, WHO, National Regulatory Authorities or other agencies aimed at balancing regulatory concerns with the need to rapidly assess promising preventive agents.
- Visits universities, research institutions, commercial organizations, government agencies, and public and private organizations for such purposes as promoting PATH’s vision and objectives in assigned program area; exchanging information; stimulating interest in collaboration with research groups and pharmaceutical firms; and developing collaborations and partnership towards common goals.
- Professional knowledge of ongoing research in infectious diseases, including the latest developments and advances in vaccine research as well as advanced knowledge of clinical research trials methodology.
- Demonstrated leadership and project/program management skills.
- Ability to multitask, simultaneously handling disparate projects of significant complexity.
- Recognized as an expert in the field and able to represent PATH in professional and technical environments.
- Ability to establish collaborative and working relationships with other scientists and interact effectively with representatives /officials of Government agencies, universities and other research institutions and organizations, advocacy groups, voluntary organizations, and the pharmaceutical/biotechnology industry.
- A high degree of initiative, independent judgment and resourcefulness.
- Excellent oral and written communication in English and ability to write clearly, logically and persuasively on scientific/medical issues for diverse audiences.
Medical degree plus a minimum of ten years of related experience in clinical research, or equivalent combination of experience and education. Must have planned, developed and managed complex applied/clinical trials programs and handled complex and or controversial ethical and regulatory medical research issues. Prefer experience in low resource countries.
Senior Medical Officer, Vaccine Development Global Program
Post a Comment