The Gates Foundation’s Global Health Program (GHP) harnesses advances in science and health technology to save lives in low and middle income countries. We focus on the health problems that have major impact in these countries but get too little attention and funding to overcome their challenges. Where proven tools exist to address these problems, we support sustainable ways to improve their delivery to people in need. Where they don’t, we invest in research and development of new interventions, such as drugs, vaccines, and diagnostics. Our work in infectious diseases focuses on strategies to fight and prevent HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, enteric and diarrheal diseases, and pneumonia. The Integrated Development (IDev) organization within the Global Health division comprises three teams focused on Quantitative Sciences, Regulatory Affairs, and Chemistry and Manufacturing and Controls. IDev plays a lead role in advancing the development of products and interventions that support our infectious disease team strategies across Global Health.
The IDev division is recruiting a new member for regulatory affairs. This person will serve as a Senior Advisor to the regulatory team. Working with internal Program Strategy Teams and external grantee partners, this position will be responsible for providing expert guidance on regulatory approaches to inform program strategy decisions with emphasis across the Global Health portfolio and partnering with internally and externally to build competent and efficient regulatory systems in LMIC. The Senior Advisor will work closely with the regulatory team, the domain leads, senior leadership at the foundation, other senior advisor and the Director of IDev.
As part of the regulatory - the Senior Advisor will contribute to the continued development of the team’s strategic vision and engaging at the Global Health Program level. Specifically, the Senior Advisor will be responsible for providing systems support to LMIC and the African Medicines Agency in addition to:
- Provide Regulatory and overall drug development advice to key foundation partners, including participation in strategic meetings, committees and boards; represent the foundation in related forums.
- Provide internal review of program and or functional grants.
- Provide programmatic expertise and support a division in developing, modifying, and implementing its strategy.
- Provide briefings to educate the staff on program related issues.
- Interact and communicate clearly and consistently with grantees and partners in the field.
- Participate in technical meetings and provide programmatic expertise.
- Attend meetings to represent the foundation and shape global, regional and country agendas in line with foundation priorities.
- Provide systems support to LMIC and the African Medicines Agency
- Excelled in prior leadership positions
- Health product development expertise ideally with industry and regulatory experience
- Demonstrated ability to synthesize technical information towards strategic decisions; along with the ability to articulate the value propositions from both a business and technology perspective.
- Strong diplomacy and partnership skills, with the ability to successfully influence senior level stakeholders in pharma/industry/global health roles.
- Demonstrated ability to work with efficiency, diplomacy, and flexibility particularly as part of a team effort.
- Ability to prioritize, focus and achieve results in a fast paced and complex environment.
- Ability to travel up to 25% domestically and internationally
- A sense of humor
- Demonstrated passion for the Foundation’s values with commitment to deliver results against the Foundation’s mission.
- Comfortable in an international environment and can interpret the multi-cultural nuances in language and action.