Consultant-Senior Regulatory Reviewer (Avaref Clinical Trial Pilot)

%3Ch2 style=%22text-align:justify;%22%3E1. %26nbsp; %26nbsp;. Background and Justification%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EAccess to innovative, affordable, safe, and effective medicines, vaccines, and health technologies of assured quality is key to enhancing Africa’s disease-fighting capacities, pandemic readiness, prevention, control, elimination, and eradication of the high communicable and non-communicable disease burden.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3EResearch and development (R%26amp;D) and manufacturing capacity for these health products in Africa continues to be very low, leaving the tremendous economic and health benefits unlocked. Among the reasons for the low participation in R%26amp;D of medicines and vaccines are weak regulatory systems for oversight of clinical development and registration, inadequately resourced clinical trial sites, unwillingness of product developers and sponsors to bring clinical trials to Africa due to fewer experts, poor governance and lack of transparency, and prolonged timelines for evaluation of clinical trial applications by both National Ethics Committees (NECs) and National Regulatory Authorities (NRAs), and the fragmented regulatory systems in the 55 member states including approvals.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3EAVAREF, Ad. Vancing Clinic. Al TRials Excellence in AFrica, is a network of NRAs and NECs established 19 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.

The AVAREF Secretariat situated within Vaccine Research and Innovation Unit (VRUI) within the Vaccine Preventable Diseases (VPD) Program 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 programs with partners and stakeholders.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3ETo effectively address long standing irritants and bottlenecks for timely regulatory and ethic oversight of clinical trials in Africa, AVAREF initiated the Clinical Trial Pilot project following the Advisory Committee meeting in Dakar (September 2024), with 16 member countries selected based on the number of clinical trials, regional representation, regulatory maturity levels, and readiness to participate in this new phase of reliance-based regulatory collaboration.

These member states nominated 3 reviewers each, a total of 48 expert reviewers across clinical, non-clinical, and quality domains, to be part of the pool of reviewers to form the basis of the reliance network; benefit from continuing education from preparatory workshops and seminars to be held over the 2 year period; hold meetings to map and harmonize regulatory frameworks; identify national gaps and opportunities for harmonization towards the establishment consistent frameworks for clinical trial oversight.

It is an ambitious initiative designed to align regulatory and ethical review systems across the continent. Throughout the 2-year pilot, a digital platform for CTA submissions, harmonized SOPs, and coordinated review protocols would be developed and/or perfected. It is anticipated that the pool of reviewers would be a resource for CTA reviews to ensure high quality and timely decisions.

The project requires expert support staff who are experienced regulatory scientists and reviewers with extensive experience from world class regulatory agencies (ML-4) agencies.%3C/p%3E%3Cp style=%22text-align:justify;%22%3EThe ecosystem within which AVAREF operates require a Secretariat supported by highly competent professionals who are motivated, skilled with the right competencies, expertise, and experience to facilitate the delivery of results.

As part of the program of work, AVAREF Secretariat is responsible for the developing the pool of reviewers within the network to support the goal of attracting clinical trials to the continent.%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E2. %26nbsp; %26nbsp;. Deliverables%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EThe Consultant Senior Regulatory Reviewer – AVAREF Clinical Trial Pilot (Clinical) will work closely with the Coordinator, AVAREF Secretariat, the staff within the Secretariat, member states, especially the 48 reviewers from the 16 countries in the AVAREF clinical trial pilot project as a coach, mentor, and second reviewer to support their development within the 2-year pilot period.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EAVAREF Clinical Trial Pilot Project%3C/strong%3E%3Cbr%3EThe AVAREF CT pilot is a major initiative for AVAREF as it implements its 2024-26 Strategic Plan and a foundation for its re-positioning in the current dynamic environment. The 16-member country initiative is an alternative model for provision of clinical trial oversight for Africa as well as lever for the ecosystem and life cycle approach.

Given that the pool of reviewers will need coaching and mentorship as they develop the necessary skills for the evaluation of CTAs and other functions, it is imperative that this is provided by an experienced clinical trial evaluator with solid experience.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3ESupport for Multi-country Joint Reviews, Scientific Advice, and Facilitated Registration%3C/strong%3E%3Cbr%3EThe AVAREF Secretariat supports member states by providing a platform for multi-country joint reviews, scientific advice for clinical trials as well as facilitated registrations for emergency use authorizations of medicines for public health.

This function requires expert support and advice, specifically for the nominated reviewers as the process integrates capacity strengthening. The consultant will therefore provide the expert support needed for this critical and landmark function.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EReviewer Capacity Strengthening Initiatives%3C/strong%3E%3Cbr%3EAVAREF’s core function includes capacity building and strengthening to NRAs and NECs.

Initiatives such as the training of reviewers through various workshops and/or direct country support. Further the Consultant can support AVAREF modernization efforts including updating the guidelines, tool, and procedures to support harmonization and standardization.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3ESpecifically, the Consultant will perform the following tasks:%3C/strong%3E%3Cbr%3E• Provide training, mentorship, and coaching for the evaluation of clinical trial applications, especially the clinical component of the dossiers to the pool of reviewers within the clinical sub-group.

%3Cbr%3E• Support the development of updated guidelines, SOPs, and checklists used for the review of clinical trial applications, specifically the clinical component.%3Cbr%3E• Support the ongoing multi-country joint reviews, scientific advice, and facilitated registrations for clinical trials and emergency use authorizations.

%3Cbr%3E• Develop and deliver training workshops such as comprehensive clinical trial application review and writing assessment reports.%3Cbr%3E• Other related functions as determined by the AVAREF Coordinator.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EExpected Outputs%3C/strong%3E%3Cbr%3E• A report on the coaching and mentorship provided to the Reviewers of the AVAREF Clinical Trial Pilot program.

%3Cbr%3E• A report for participation in the AVAREF multi-country joint reviews and scientific advice for clinical trials as well as facilitated registrations.%3Cbr%3E• Facilitating AVAREF workshops as required.%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E3. %26nbsp; %26nbsp;. Qualifications, experience, skills and languages%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EIdentify the educational qualifications and expertise needed for the terms of reference outlined above.

%3C/p%3E%3Ch4 style=%22text-align:justify;%22%3EEducational Qualifications%3C/h4%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EEssential:%3C/strong%3E Doctorate in Medicine, Biomedical Sciences, Health Sciences; or Advanced university degree (Masters or higher) in a health-related field (medicine or health).%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EDesirable:%3C/strong%3E%3Cbr%3EAdvanced degree in medicine / public health / communicable/non-communicable diseases.

%3Cbr%3ENon-clinical and safety specialization in review of clinical trial and/or registration dossiers. Toxicology, Pharmacology, Microbiology.%3Cbr%3EAdvanced degrees in Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.%3Cbr%3EClinical specialization in Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology.

%3C/p%3E%3Ch4 style=%22text-align:justify;%22%3EExperience%3C/h4%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EEssential%3C/strong%3E%3C/p%3E%3Cp style=%22text-align:justify;%22%3ESignificant experience (at least 10 years) working in an internationally recognized national regulatory agency (ML-4).%3Cbr%3ESignificant experience (at least 10 years) in aspects of regulation of medicines including vaccines, biotherapeutics, pharmaceuticals, advanced therapeutics, diagnostics.

%3Cbr%3ESignificant experience (at least 10 years) in the review of clinical trial dossiers, registration of new and/or existing medicines.%3Cbr%3ESignificant experience (at least 10 years) in regulation of biotherapeutics, biosimilars, other biologics.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EDesirable :%3C/strong%3E%3Cbr%3EDemonstrated experience in medicines review and approval process in an internationally recognized national regulatory agency.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EExpertise requirements:%3C/strong%3E%3C/p%3E%3Cp style=%22text-align:justify;%22%3EExpertise in review of non-clinical and clinical data for vaccines and drug registration dossiers, Good Clinical Practice Inspection (GCP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Post Marketing Surveillance and monitoring, Biostatistics, Pharmacovigilance, or Pharmacoepidemiology.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3EExpertise in clinical specialties such as Allergy and immunology, Anesthesiology, Cardiology, Dermatology, Diagnostic radiology, Emergency medicine, Family medicine, Internal medicine, Medical genetics, Neurology, Nuclear medicine, Obstetrics and gynecology, Ophthalmology, Oncology, Pathology, Pediatrics, Physical medicine and rehabilitation, Preventive medicine, Psychiatry, Radiation oncology, Surgery, or Urology.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3EMinimum of 10 years of experience in an internationally recognized National Drug Regulatory Agency which has ML-4.%3C/p%3E%3Cp style=%22text-align:justify;%22%3EExperience in international agency, government, academia, industry, or research organizations with extensive analytical, deductive, and writing skills (publications in scientific journals).

%3C/p%3E%3Cp style=%22text-align:justify;%22%3EProven skills in communication and delivery of results.%3C/p%3E%3Cp style=%22text-align:justify;%22%3EAbility to work as a team under tight deadlines and work.%3C/p%3E%3Cp style=%22text-align:justify;%22%3EExperience working in Africa (or low- and middle-income countries) as well as in advanced economies.

%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3EOther Skills:%3C/strong%3E%3Cbr%3EExcellent knowledge of data collection tools, Statistical packages, Communication packages and Microsoft application (e.g. Excel, Word, Power Point, etc.), xml.%3Cbr%3EKnowledge of project management software.%3C/p%3E%3Cp style=%22text-align:justify;%22%3E%3Cstrong%3ELanguages and level required%3C/strong%3E%3Cbr%3EExcellent knowledge of English and French and working knowledge of the other language will be an asset.

%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E4. %26nbsp; %26nbsp;. Technical Supervision%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EThe Incumbent will be supervised by the Technical Officer, Implementation Research Portfolio Coordinator, AVAREF Secretariat (WHO-AFRO).%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E5.

%26nbsp; %26nbsp;. Location%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EOff-site (Home based).%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E6. %26nbsp; %26nbsp; Remuneration and budget (travel costs excluded)%3C/h2%3E%3Cp style=%22text-align:justify;%22%3EBand level B

• USD 7,000 - 9980 per month.%3C/p%3E%3Ch2 style=%22text-align:justify;%22%3E7. %26nbsp; %26nbsp; Additional information%3C/h2%3E%3Cp style=%22text-align:justify;%22%3E%3Cspan style=%22font-family:%26quot;. Aptos%26quot;,sans-serif;font-size:12.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-ansi-language:EN-US;mso-ascii-theme-font:minor-latin;mso-bidi-font-family:%26quot;. Times New Roman%26quot;;mso-bidi-language:AR-SA;mso-bidi-theme-font:minor-bidi;mso-fareast-font-family:Aptos;mso-fareast-language:EN-US;mso-fareast-theme-font:minor-latin;mso-hansi-theme-font:minor-latin;%22%3E•%26nbsp;%26nbsp;%26nbsp;%26nbsp;. This vacancy notice may be used to identify candidates for other similar consultancies at the same level.%3C/span%3E%3C/span%3E%3Cbr%3E%3Cspan style=%22font-family:%26quot;. Aptos%26quot;,sans-serif;font-size:12.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-ansi-language:EN-US;mso-ascii-theme-font:minor-latin;mso-bidi-font-family:%26quot;. 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