Purpose of consultancy

To contribute to data mining, cleaning and analysis to inform the development of WHO’s clinical pipeline review.

Background

Antimicrobial resistance is a global public health threat, acknowledged through the endorsement of the Global Action Plan on antimicrobial resistance (AMR) by the World Health Assembly (resolution WHA68.7) on May 2015, the Political Declaration of the high-level meeting of the General Assembly on AMR in September 2017 as well as the report of the UN Interagency Coordination Group (IACG) on Antimicrobial Resistance.

Objective five of the Global Action Plan is to develop the economic case for sustainable investment that takes account of the needs of all countries and increases investment in new medicines, diagnostic tools, vaccines, and other interventions. In response, in September 2017, WHO released the first bacterial priority pathogens list to prioritize R&D efforts and is currently revising the list. Coupled with this list, the WHO has undertaken an analysis of the clinical antibacterial pipeline on an annual basis and added in 2019 an annual review of the pre-clinical antibacterial pipeline and has also reviewd the pipeline of bacterial vaccines in 2022 and is looking to expand the range of pipelines to include the revision of the antifungal candidates under development.

The pipeline analyses aim to assess the robustness of the clinical and preclinical pipeline overtime against the bacterial priority pathogens to drive R&D efforts of new therapeutics. To facilitate the clinical pipeline analyses, this consultancy is to hire a short-term clinical R&D expert to support data mining, cleaning and analyses and support the final report writing and a scientific publication on agents in clinical development. The data will be used for WHO advocacy, dissemination and implementation activities and will be used also to feed the WHO Global Observatory on Health Research and Development (R&D) and the Global AMR R&D Hub, Berlin, Germany.

Deliverables

Clinical antifungal pipeline review.

• Deliverable 1: Contribute to the development of WHO clinical pipeline reviews of antifungal targeting the WHO fungal priority pathogens list (WHO FPPL).
  • Verify data from different sources including literature review, desk review, expert opinion and any additional sources, and compile into an Excel file.
  • Clean, proofread, and verify all data for submission and final validation by the WHO R&D Advisory Group.
  • Communicate with project partners to verify data quality and complement data gaps in close collaboration with the WHO IRC team.
  • Submit all data, including verified data set in Excel as well as supporting documents/articles and references, to WHO to be stored for future reference and pipeline report iterations.
    Expected by: March 2024
• Deliverable 2: Contribute to presenting the clinical data collected and the analyses performed, and discussing potential outstanding issues.
  • Develop relevant background documents and a power-point presentation with the results of the clinical pipeline review.
  • Identify potential areas for discussion.
  • Participate in preparatory pre-meeting calls with the AG Chair and and present data in the AG meeting.
    Expected by: April 2024
• Deliverable 3: Contribute to drafting sections of the antifungal pipeline report focused on antifungal agents in clinical development. Draft sections on methodology, clinical agents, discussion and conclusion, with input from WHO IRC staff and consultants.
  Expected by: May 2024

Clinical antibacterial pipeline review.

• Deliverable 4: Contribute to the development of WHO clinical pipeline reviews of antibiotics and antibacterials targeting the WHO bacterial priority pathogens list (WHO BPPL).
  • Verify data from different sources including literature review, desk review, expert opinion and any additional sources, and compile into an Excel file. This should include product name, developer, phase, antibiotic class, route of administration, expected activity against the WHO bacterial priority pathogens list, an assessment of the potential innovativeness of each product against the WHO innovation criteria as well as the funder/s for each product.
  • Clean, proofread, and verify all data for submission and final validation by the WHO R&D Advisory Group.
  • Communicate with project partners to verify data quality and complement data gaps in close collaboration with the WHO IRC team.
  • Submit all data, including verified data set in Excel as well as supporting documents/articles and references, to WHO to be stored for future reference and pipeline report iterations.
    Expected by: June 2024
• Deliverable 5: Contribute to presenting the clinical data collected and the analyses performed, and discussing potential outstanding issues. Develop relevant background documents and a power-point presentation with the results of the antibacterial clinical pipeline review. Identify potential areas for discussion. Participate in preparatory pre-meeting calls with the AG Chair.
  Expected by: July 2024
• Deliverable 6: Contribute to drafting sections of the antibacterial pipeline report focused on antibacterial agents in clinical development. Draft sections on methodology, clinical traditional and non-traditional agents, discussion and conclusion, with input from WHO IRC staff and consultants.
  Expected by: September 2024
• Deliverable 7: Draft a scientific article on antifungal agents in clinical development based on the above analyses, for submission to relevant peer-reviewed journals/periodicals.
  Expected by: September 2024

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced degree (Ph.D) in pharmacology, immune pharmacology, clinical pharmacology, biomedical sciences, microbiology or another relevant area specific to antimicrobial resistance and infectious disease.

Experience

Essential:

• Over 10 years of relevant experience in the regulation and evaluation of medicinal products with experience in scientific advice on R&D of pharmaceuticals at international level.
• Experience in drug evaluation, in the benefit/risk assessment and in establishing the clinical benefit of medicinal products.
• Experience in the evaluation of clinical trials studies (phase 1-3, MAAs/NDAs) and regulatory assessment of human medicinal products.
• Experience in advising on clinical trial design (phase 1-3, MAAs/NDAs).
• Experience in the R&D of pediatric medicines.
• Experience in Health technology assessment of medicines including antibiotics.
• Experience in developing clinical guidelines (drug formularies) on antibiotics.
• Experience conducting R&D pipeline reviews for WHO.

Desirable:

• Experience working for the UN in an international context.
• Drug development experience that spans across quality, non-clinical, clinical and pharmacovigilance in the regulatory dossiers supporting the submissions for a marketing authorization.

Skills:

• Expert knowledge of clinical pharmacology, drug evaluation, research and development of pharmaceuticals.
• Proven skills in scientific writing.
• Ability to work independently and in a team.
• Ability to work under pressure with conflicting priorities.
• Excellent interpersonal and communication skills.
• Computer literacy (Microsoft office including Excel, zoom, etc.).

Languages required:

Essential:

Expert knowledge of English.

Location

Off site: Home-based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C – USD 10,000 – 12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

11 months part-time at 33%. Remuneration will be pro-rated accordingly.

Additional Information

• 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.
• For information on WHO’s operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html