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Senior Advisor for Development of Biomedical HIV Prevention Technologies

Senior Advisor for Development of Biomedical HIV Prevention Technologies

# of Openings 
1
Job Locations 
US-VA-Arlington
Category 
Global Health
Type 
Regular Full-Time

More information about this job

Overview

CAMRIS International is an international development and research firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. With experience working in more than 80 countries, we combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world.

                             

The United States Agency for International Development (USAID) has contracted through Social Solutions International partnered with CAMRIS International, to recruit and hire qualified individuals for the following position:

 

Title: Senior Advisor for Development of Biomedical HIV Prevention Technologies

 

United States Agency for International Development/Bureau for Global Health/Office of HIV/AIDS/Research Division, Microbicide Branch (GH/OHA/RES)

Application Deadline:   Open until Filled

 

 INTRODUCTION

The U.S. Agency for International Development (USAID) is at the forefront of the U.S. Government (USG) response in the fight against HIV/AIDS. The USAID Office of HIV/AIDS has primary responsibility for leading the Agency's efforts within the President's Emergency Plan for AIDS Relief (PEPFAR), a $52 billion multifaceted approach to combating the disease in more than 120 countries around the world since 2003. In collaboration with the US Department of State Office of the Global AIDS Coordinator (OGAC), other USG partners (including NIH, CDC, DOD, and Peace Corps), international organizations, and nongovernmental organizations, USAID provides technical leadership on the full range of issues related to HIV/AIDS prevention, care, and treatment; manages numerous research and field support programs; and monitors the impact of the Agency's programs. More information about PEPFAR is available at http://www.usaid.gov/what-we-do/global-health/hiv-and-aids.

As part of this effort, USAID has a long and substantial history of supporting innovative research to develop new technologies for the prevention of HIV infection as well as implementation research to improve HIV/AIDS intervention programs in the field. This includes the research and development (R&D) of safe, effective, and affordable microbicides – biomedical products that women can use to protect themselves from HIV infection – especially microbicides that can be sustainably provided in PEPFAR focus countries in Sub-Saharan Africa for the women who need them most, including adolescent girls and young women.

The USAID Microbicide Program currently includes 1) Earlier-stage research for improved product leads, including those with new active ingredients and innovative delivery systems, such as biodegradable implants, microarray patches, broadly neutralizing antibodies, and vaginal inserts, 2) Later-stage development of the most promising and advanced new products, such as vaginal rings, improved oral tablets, and long-acting injectables, and 3) Preparatory activities needed for successful microbicide introduction and access, including targeted behavioral studies, implementation and impact modeling, and policy or regulatory development. With an end-user focus, research is used to tailor products that will fit into and enhance women’s lives and which have the potential for successful delivery in developing country settings. Other research also suggests that the most effective product use and greatest prevention impact will be achieved when users can consider several product options – including multipurpose products that prevent other sexually transmitted infections or pregnancy as well as HIV – and choose the one that is best for them and their circumstances at the time.

The most advanced microbicide product receiving USAID support is the dapivirine vaginal ring. The landmark 2016 results of two large clinical trials demonstrated that this product, developed by the International Partnership for Microbicides (IPM), is safe to use and significantly reduces the risk of HIV infection. This product has now advanced to an open-label follow-on study, the DREAM Study, that will collect additional safety data, investigate real-world options for product delivery, and importantly, evaluate if correct and consistent ring use will increase when women know that the ring is safe and effective. Simultaneously, preparations are underway to obtain regulatory approval of the dapivirine vaginal ring from the European Medicines Agency, the US FDA, and regulatory authorities in African countries, and to scale-up manufacturing and advance to product introduction as soon as possible.

The USAID Microbicide Program has also created the Microbicide Product Introduction Initiative (MPii) to prepare for and expedite the introduction of biomedical products that women can use to protect themselves from HIV infection, including currently approved and recommended approaches such as oral PrEP as well as other new microbicide products advancing toward regulatory review, such as the dapivirine vaginal ring. These activities have a particular focus on adolescent girls and young women at higher risk in Sub-Saharan Africa, contribute substantially to the PEPFAR DREAMS Initiative, and will be critical to achieving PEPFAR prevention targets in the future. MPii projects address specific elements that are fundamental to successful microbicide introduction at the national, facility, and end-user levels.

Building on the ongoing technical achievements of the microbicide field and the potential for future programmatic impact of these technologies, USAID is committed to working with stakeholders to define and achieve the steps needed to demonstrate the effectiveness of new products, expedite licensure, prepare for introduction after regulatory approval, and ensure sustained access to these products in the future, especially for women in Africa, where the need is great.

 

The Senior Advisor for Development of HIV Prevention Technologies will be located in the Microbicide Branch of the Research Division, Office of HIV/AIDS, and Bureau for Global Health, and the USAID Point of Contact will be the Microbicide Branch Chief. As part of a team of technical and management professionals, this position will support USAID’s further development and implementation of HIV prevention technologies, especially microbicides and oral PrEP in the near term, as well as alternative ARV-based products, vaccines, and other novel approaches in the future. This will require working with other teams such as the Care and Treatment, Supply Chain Management, and Prevention teams, as well as with other offices in the Bureau for Global Health. Significant engagement with USAID mission staff, partners in the field, and other target-country stakeholders in all sectors will also be essential. The specific roles and responsibilities of this position are described below.

 

Responsibilities

The primary role of the Senior Advisor for Development of HIV Prevention Technologies will be to provide expert technical advice, strategic guidance, and programmatic insight in preparation for the introduction of microbicides, oral PrEP, and other new HIV prevention technologies, including, for example, support for regulatory approval, product scale-up, policy development, and/or other stakeholder engagement. In this role, the Senior Advisor for Development of HIV Prevention Technologies will be a key technical resource in GH/OHA regarding activities related to microbicides and other HIV prevention technologies, and will participate in defining program priorities and budgets, and serve as a liaison with other offices at USAID/Washington and USAID missions, as well as with national product regulatory authorities, relevant private sector parties, and other donors and agencies involved with microbicide and HIV prevention programs. This position will support Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008) as part of USAID’s goal to facilitate the availability and accessibility of microbicides and other new biomedical technologies for HIV prevention that are approved by stringent regulatory authorities and authorized for use in USG programs.

Specific responsibilities may include but not be limited to the following.

  • Serve as a key resource for implementation of new microbicides, including oral PrEP, and other new HIV prevention technologies, providing recommendations and suggestions on program priorities and budgets
  • Help design, implement, and analyze introduction-related projects and activities for microbicides and other new HIV prevention technologies, including, for example, support for regulatory issues, manufacturing scale-up, procurement and supply chain management, policy development, service delivery, and/or advocacy and community engagement. This may include technical assistance in developing new procurements, review of work plans and budgets, other project management responsibilities, and overall guidance on program strategy.
  • Provide technical assistance and recommendations to support improved design of HIV prevention products in both early and late stages of development that will be acceptable to users and cost effective for use in resource-constrained countries. This will include working with microbicide developers and funders to ensure that target product profiles are well aligned and include appropriate parameters related to cost, scale-up potential, and uptake by end-users.
  • Provide technical assistance for USAID-funded activities, including continued development of the dapivirine vaginal ring and other promising agents and formulations that include regulatory, costing, and manufacturing components; support for other HIV prevention technologies; and engagement with key stakeholders.
  • Provide USAID field Missions, PEPFAR country programs, host-country governments, and implementing partners with expert input to country-specific strategic planning for the introduction of microbicides, including oral PrEP, and other HIV prevention technologies.
  • Coordinate with other USG agencies and partners supporting microbicide and related HIV prevention activities, including participation in meetings with the National Institute of Allergy and Infectious Diseases (NIAID)/Division of AIDS and Division of Microbiology and Infectious Diseases; the National Institute of Mental Health (NIMH); and the NIH Office of AIDS Research (OAR); as well as in other meetings or conferences that would assist in managing the USAID project portfolio.
  • Support USAID interests in the implementation of biomedical technologies for HIV prevention, including microbicides and oral PrEP, in meetings, conferences, and other communications with private and public sector partners, including but not limited to product development partnerships, pharmaceutical companies, marketing firms, multilateral agencies (e.g. WHO, UNAIDS), and product procurement programs.
  • Coordinate with other donors to maximize the progress, cost efficiency, synergy and effectiveness of USAID activities.
  • Contribute to USAID leadership on coordinating committees and working groups organized by civil society, private sector, or multilateral agencies, or host country governments when related to introducing microbicides, oral PrEP, or other new HIV prevention products.
  • Serve on OHA and GH Research Committees, and PEPFAR Technical Working Groups, when biomedical technologies for HIV prevention are relevant and may impact other programs.
  • Assist in drafting responses to Executive, Congressional, Agency, and public inquiries about USAID activities related to biomedical technologies for HIV prevention.
  • Assist with the preparation of regular and ad hoc reports requested by USAID, OGAC, Congress, and others.
  • Draft and provide technical documents and state-of-the-art presentations for colleagues both within and outside USAID.

Qualifications

  • Advanced academic degree (Masters or beyond) in a field related to new product regulatory affairs, scale-up, and introduction, and to international health programs and development
  • Experience in new health product introduction, and preferably with HIV prevention technologies
  • Demonstrated ability in project design, implementation, oversight, and evaluation
  • Demonstrated expertise in data analysis and application
  • Demonstrated experience across academic, public, and private sectors
  • Excellent written and oral communication skills
  • Demonstrated experience and preference to be a collaborative team participant and leader
  • Willingness and ability to travel internationally (up to 25%)
  • US Citizenship due to ability to obtain a SECRET security clearance

 

This is an opportunity for employment or a contract, but we reserve the right to make no selection or award.

Social Solutions International and CAMRIS International offer competitive salaries and comprehensive benefits. Please submit your resume online at www.camris.com

Social Solutions and CAMRIS are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.