Senior Program Officer, Smart Safety Surveillance, Integrated Development
Bill & Melinda Gates Foundation
We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities. As a workplace, we’re committed to creating an environment for you to thrive both personally and professionally.
The TeamOur Global Health Program (GHP) harnesses advances in science and technology to save lives in poor countries. We focus on the health problems that have a major impact in developing countries but get too little attention and funding. Where tools exist, we support sustainable ways to improve their delivery. Where they don’t, we invest in research and development of new interventions, such as vaccines, drugs, 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, pneumonia, and maternal, newborn and child health. These strategies are supported by functional & cross cutting teams that focus on Discovery and Translational Sciences, Innovative Technology Solutions, Vaccine Development, Innovation Introduction, and Integrated Development.
The Integrated Development (IDev) team comprises sub-teams passionate about: Regulatory Affairs, Chemistry, Manufacturing and Controls, and Quantitative Sciences. IDev plays a meaningful role in advancing the development of products and interventions that support our team strategies across Global Health.
Reports to: Deputy Director, Regulatory Affairs, Integrated Development. The role is targeted to be based out of Seattle, WA, however we can also consider those in the Washington, D.C. area and may consider a remote US worker arrangement for the selected professional.
The IDev Regulatory Affairs team is looking for an outstanding Senior Program Officer (SPO) who will support our global Smart Safety Surveillance (3S) strategy. The SPO will be responsible for owning and supporting a portfolio of systems (product-agnostic) grants and investments within our 3S and domain strategy, focused on building functional pharmacovigilance systems in LMICs. Our grantee partners are organizations across Africa, Asia, and the Americas, working to promote patient safety as a priority issue, such as the World Health Organization, the African Union, Regional initiatives, LMIC public health programs, LMIC regulatory agencies and other relevant partners. Work is done in close collaboration to ensure effective grants development and implementation and their integration into and coordination with the foundation's overall global health strategies. A particular focus will be our current partnership with the African Union on AU-3S, building a centralized continental approach to pharmacovigilance in Africa to serve a future African Union Medicines Agency as needed,
What You’ll Do
- Play a central role in determining the wider strategy for 3S and the domain, ensuring operational implementation by partners, and increasing internal & external awareness of safety as a priority within global health. Pharmacovigilance is becoming a pressing concern as more products are being targeted directly to LMICs and are undergoing accelerated approval with limited safety data packages. In order to protect the health of patients once a product is launched in a larger population, it is critical to then have functional safety systems for collecting, analyzing, and making evidence-based decisions on any adverse events seen.
- Collaborate with other Regulatory team members (who are responsible for developing product-specific regulatory strategies) to ensure that the changes being catalyzed by 3S in these LMIC safety pathways are being fully maximized by our product development grantees to accelerate access to safe quality health products.
- Partner with our PSTs (Product Strategy Teams) as needed on product safety-related issues. Examples include advising on pre- and post-approval LMIC safety commitments for their priority products, creating linkages between product development grantees and LMIC safety stakeholders, etc.
- Responsible for cultivating high quality interactions, and clear and consistent communications with internal teams, grantees, and external partners.
- Financial responsibility for either grant making and/or operating budget as determined under Delegation of Authority
- Solid understanding of clinical product development, registration, and regulatory life-cycle, including ideally pre- and post-approval safety. Some experience with products targeting global infectious diseases and/or LMIC experience is preferred. Knowledge of major industrialized country regulatory processes and considerations (e.g. FDA, EMA, and WHO PQ).
- The ideal candidate will have strong management capabilities and will have handled a diverse portfolio.
- Broad knowledge of global health issues, regulatory procedures, product development, and product safety; at both global and national levels is helpful.
- This could be gained from 7+ years of demonstrated ability in product development within Pharma/Biotech, other life sciences domains, or in regulatory science at Regulatory Agencies and similar organizations.
- M.D., PhD, MBA, or other graduate degree preferred.
- Experience with other HIC and LMIC national regulatory authorities (e.g. Africa, Australia, India, China, and South Africa) is preferred.
- Experience with product safety monitoring and pharmacovigilance systems preferred
The typical salary range for this role is $144,200 to $267,800 USD. The exact offer will be determined by a variety of factors such as the candidate’s individual skills, qualifications, and experience relative to the requirements of the role.
As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.
Depending upon your work location, we may require proof of full vaccination against COVID-19 and any recommended booster doses. All employees based in the United States are to provide proof of full vaccination upon hire and any recommended boosters, subject to applicable laws.
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We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion — of voices, ideas, and approaches — and we support this diversity through all our employment practices.
All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.