CONSULTANT–TECHNICAL COMMITTEES, STANDARDS DEVELOPMENT, KNOWLEDGE AND PROJECT MANAGEMENT (AVAREF PROGRAM)

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AVAREF, AdVancing ClinicAl TRials Excellence in AFrica, is a network of National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) established 20 years ago by the WHO with its primary mission for capacity building of the NRAs and NECs. AVAREF is leveraging its strong network of NRAs and NECs and associated platform to enhance vaccine research and development through excellence in clinical trials. The AVAREF Secretariat situated within the Vaccine Research and Innovation Unit (VRIU) within the Vaccine Preventable Diseases (VPD) Programme is responsible for delivering on the workplan for a wide range of activities including capacity building initiatives, technical assistance to member states, and coordination of programmes with partners and stakeholders.

In the last two decades, since 2006, AVAREF has achieved a great deal and been involved in the attainment of major milestones for the clinical trial ecosystem. AVAREF has been instrumental in facilitating research and development through clinical trials by the increase in maturity levels for NRAs (currently 8 out of the 48 member states in the region); use of the AVAREF platform to support the registration of emergency use vaccines for Ebola, COVID-19, and Mpox; supporting the clinical development, clinical trials, and approvals of key public health vaccines, including RTS,S (malaria), meningitis (Neisseria meningitidis and Streptococcus pneumoniae), Ebola, rotavirus, pneumonia, Covid-19, cholera, and cervical cancer; contributing to capacity building and strengthening for a wide range of reviewers within NRAs – training 120 individuals in 2024 and 67 specialists in 2025; all making AVAREF a globally recognized model of regulatory harmonization and excellence on the continent.

AVAREF has been implementing its 2024–26 Strategic Operational and Action Plan which contains three main pillars (partnerships for results, trusted expert support, and life cycle approach) on which its main activity of excellence in capacity building rests, and is developing a 10-year (2025–35) Strategic Plan of Action. The landscape within which AVAREF operates has changed significantly, with 8 member states attaining maturity level 3 (ML-3) and others in line. AVAREF deals not only with vaccines but all therapeutic products. AVAREF finds itself within a highly competitive environment which requires hard transformations to respond to drastic funding reductions, an increasing number of well-funded organizations with similar mandates (namely Africa CDC and AMA), and donors streamlining their funding. In response, AVAREF is transforming from a Secretariat to a programme through building on its existing core body of work such as development of norms and standards for clinical trials, capacity strengthening, and provision of knowledge products.

With the operationalization of AMA, the quest for local production of vaccines as part of the health sovereignty agenda, significant changes in the financial environment with an increasing tendency of traditional donors consolidating their funding envelopes, direct competition amongst African Union organizations and WHO due to overlapping mandates, and the need for clear value addition, AVAREF is transforming into a WHO-AFRO Programme focused on an ecosystem and life cycle approach from R&D to safe use of vaccines.

The AVAREF Programme requires professionals who are competent, motivated, and skilled with the right competencies, expertise, and experience to facilitate the delivery of results. The ability to attract and retain sustainable funds requires delivery of results from ongoing funded initiatives. AVAREF has funding from Wellcome Trust specifically intended for the development of guidelines for assessing complex clinical trials through external working groups managed by AVAREF. These working groups have been in hiatus due to expired consultant contracts. Other key initiatives that have halted include biostatistics training, development of guidelines for anti-snakebite venoms, and ongoing data collection, assessment, and analysis. The consultant is required to advance these work products and attain deliverables critical to the AVAREF Programme.

The Consultant will work closely with the Coordinator, AVAREF Programme, as well as the staff within the Secretariat to support the delivery of results for AVAREF in the African Region by performing the following tasks:

The consultant will work closely with the Coordinator, AVAREF Programme and the vaccine research, regulatory, and safety team to perform the following tasks:
• Support AVAREF Expert Working Groups for Challenge Human Infection Model Studies and Snakebite Antivenoms
• Consolidation, review, and updating of Draft Guideline for clinical trials involving CHIM studies
• Continuation and completion of the Guidelines for clinical trials involving Snakebite Antivenoms
• Working Group on Clinical Trials during public health emergencies

• Leveraging the 16-member reliance network, establish networks for NECs, Clinical Trial sites, Vaccine R&D, and Vaccine Manufacturers as part of the ecosystem and life cycle approach.
• Development of foundations for effective coordination of the networks, establishing TORs, work plans, etc.

• Support the AVAREF website and social media presence through regular posting of knowledge products, news, and other noteworthy events.
• Contribute to the development of an Internal Communications and Media Strategy.

• Effective management and coordination of Working Groups to maximize deliverables for norms and standards, technical documents including guidance documents
• Finalization of the Guidelines for clinical trials for CHIM studies
• Development of Guidelines for clinical trials for anti-snake venom products
• Revision of guidelines for Clinical Trials in Public Health Emergencies
• Ecosystem data collected, analyzed, reported, and knowledge translated
• Clear links with AVAREF Programme focal points in WHO Country Offices and reliance network focal points established
• Regular reporting of performance indicators from surveys to provide state of the ecosystem reports
• Workshops, training, and convenings supported
• New networks for Research and Development, Vaccine Manufacturers, and Clinical Trial Sites established
• 16-member reliance network leveraged to establish networks for NECs, Clinical Trial sites, Vaccine R&D, and Vaccine Manufacturers
• AVAREF website and social media presence maintained through regular posting of knowledge products, news, and noteworthy events
• Internal Communications and Media Strategy developed and implemented
• Well organized and attended AVAREF training, capacity building activities, especially in support of Francophone member countries
• Well organized and supported AVAREF activities including Secretariat support to various regulators fora, technical workshops, webinars, and virtual trainings

Essential: University degree in a health-related field, biomedical sciences, pharmacy, pharmaceutical science, or medicine.
Desirable: Postgraduate degree in a health-related or life science field, project management, or policy development; experience working with AVAREF and within National Regulatory Agencies or public health institutions.

Essential : Minimum of 5 years of combined experience in a regulatory agency, clinical research, laboratory environment, or research institution.
• Experience in policy development within a science-based organization or regulatory agency/department.
• Proven skills in results communication.
• Ability to work as a team under tight deadlines and in a multicultural environment.
• Confirmed experience of working in collaboration with a wide range of stakeholders.
• Experience working in Africa (or low-to-middle income countries) as well as in advanced economies.

• Strong leadership, communication, decision making, and problem-solving skills.
• Excellent knowledge of data collection tools, statistical packages, communication packages, and Microsoft applications (e.g. Excel, Word, PowerPoint), XML.
• Knowledge of project management software.
• Skills required in working internationally, including Africa and in developed economies.                      

Essential: Excellent knowledge of English and French;
Desirable: Intermediate knowledge the other language or any other UN official language.

The Incumbent will be supervised by the Technical Officer, Implementation Research Portfolio Coordinator, AVAREF Secretariat (WHO-AFRO)

Offsite working from home country.

Band level B - USD 7,000 - 8,480 per month

An initial duration of 6 months with the possibility of extension

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/  . Some professional certificates may not appear in the WHED and will require individual review.
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