Drug and vaccine development for Global Health applications faces additional hurdles beyond the already substantial challenges inherent in product development for high income settings. The drug product must be stable for long periods under extreme climate conditions with limited cold chain; sufficiently rugged to reach patients and providers in remote areas; easily adoptable by users with limited training and equipment; and convenient enough to promote adherence to sometimes lengthy treatment regimens. To achieve broad impact, the dosage forms must also be compatible with the needs and preferences of patients and healthcare providers across a wide range of geographies and cultures. At the same time, products for Global Health applications must be high quality as well as cost effective and affordable.
Novel drug delivery technologies have great potential to address many of these challenges. To support these programs, we are seeking a Senior Program Officer (SPO) on the Integrated Development CMC team to provide in-depth technical guidance to teams and partners developing combination products, long-acting injectables, implants, targeted and other advanced drug delivery technologies for drugs, vaccines and emerging modalities such as nucleic acid constructs. Key responsibilities include:
- Advise the foundation and manage investments in cross-cutting drug delivery technologies that can support multiple programs based on deep knowledge of the field and current developments;
- Provide detailed technical input to CMC strategies and project plans for combination products, long-acting and other complex drug delivery technology projects;
- Review data as it becomes available to assist investment teams and partners in adjusting project plans as needed;
- Assist partners in understanding the unique technical requirements and expectations for effective product development in this arena; support partners in developing their strategy, capacity and execution capability;
- Engage and direct seasoned subject matter experts to work with project teams and partners to successfully resolve specialized technical and/or CMC-related regulatory challenges;
- Assess probability of technical and regulatory success and make recommendations for project progression or timely termination.
We are looking for people who enjoy the challenge of working on complex problems and collaboratively creating solutions that have the potential for transformational change in the lives of people around the world. S/he must be prepared to work across a diverse set of disciplines, bridging a wide range of expertise all the while being a solid team player, with a demonstrated ability to work with flexibility, efficiency, and diplomacy in a fast-paced, challenging environment.
We seek an experienced professional with a demonstrated record of success in developing drug delivery technology-based products; including, preferably, more than one commercial product.
Additionally, s/he should have:
- A track record of significant accomplishments in product development with one or more complex drug delivery technologies, combined with wide knowledge and ability to support product development for Global Health based on a wide variety of drug delivery technologies. Relevant technologies include API suspensions, controlled release formulations, long duration implants, targeted delivery systems, combination products, and other formats and approaches.
- End-to-end product development experience with one or more established technologies (e.g. polymeric microparticles, implants, prefilled injection devices, etc.). Familiarity with the cutting-edge of innovation (microneedle arrays, mRNA and DNA vaccines and therapeutics, etc.) is a strong asset.
- Diverse experience with a range of product modalities including small molecules, vaccines, biologics and/or others is a significant advantage.
- Broad knowledge of the manufacturing landscape for a wide variety of drug delivery technologies. Familiarity with the CMC capabilities of non-US/non-EU based manufacturers and a track record of working successfully with partners in low cost manufacturing environments is highly desirable.
- Familiarity with quality regulations and current industry practices, as well as, the specific regulatory requirements for combination products and advanced drug delivery systems. A track record of successful interactions with regulators to address CMC-related regulatory requirements for combination products and advanced drug delivery technologies is a significant benefit.
- Experience in product development for emerging markets is a plus.
- Experience in a role requiring collaboration in a complex internal and external organizations, including a solid understanding of the realities and complexities of matrix based organizations.
- Ability to travel up to 30% domestically and internationally.
- Demonstrated capacity and initiative to solve problems with energy and a positive attitude.
- A sense of humor.
- Demonstrated passion for the foundation’s values with a commitment to deliver results against the foundation’s mission.
The Bill & Melinda Gates Foundation is dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.