As a key member of the Vaccine Development team, the Senior Program Officer, Pandemic Product Development & Clinical, Vaccine Development is accountable for a portfolio of investments and partnerships on priority product development efforts. These will consist of leading our partnership with the Coalition for Epidemic Preparedness Innovations and other pandemic/epidemic related grants and driving the associated strategy, as well as providing subject matter expertise to clinical vaccine development programs across the Global Health portfolio. You will provide clinical leadership, program management, strategy development and communications on Vaccine Development priorities, Product Development Partners, and other foundation partners. You will also partner closely with the Deputy Director (DD), Integrated Clinical Development, and Deputy Director (DD), Chemicals, Manufacturing and Controls (CMC) to contribute to the continued development of the team’s strategic vision including participating in the setting of the overall strategy and goals for the group
What You’ll Do
Define strategy for and lead the pandemic product development portfolio, working closely with the Deputy Director of Integrated Clinical Vaccines Development.
Partner closely with team leadership, including the Director, DD Integrated Clinical Vaccines Development, DD CMC Vaccine Development, and DD Strategy, Planning and Management to communicate and implement the overall Vaccine Development strategy.
Act as foundation “Project Lead” for priority vaccine development programs
Negotiate, implement, and manage a portfolio of grants or performance-based contracts; including alignment of internal and external stakeholders, review of letters of inquiry and grant proposals as well as providing clear, concise and insightful written analyses and recommendations for funding.
Consult, provide thought partnership, and support to grantees and other partners to maximize the impact of projects and the creation of well-integrated vaccine development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies.
Serve as an advisor on clinical vaccine study design; including the review of protocols, analysis plans, and clinical sections of regulatory dossiers.
Bring forward innovative ideas for enabling more rapid, cost-effective and geographically diverse clinical development of vaccines and biologics
Provide senior-level technical clinical vaccine development expertise for internal Program Strategy Teams (PSTs) and partners.
Provide technical guidance and support on the foundation process for Integrated Product Development Plans (IPDPs) and the development process including definition of critical milestones and stage gates. Support product development process as defined by the foundation for our internal and external partners.
Represent the foundation and program to the external world as relates to position responsibilities:
Forge collaborations with key global experts in vaccine development.
Work with external advisors to maintain cutting edge approaches to vaccine development.
Represent foundation interests in developing networks for the program.
Play a strategic role on clinical vaccine development related issues relevant to regulatory interactions and submissions
Identify and cultivate partners to build coalitions and achieve objectives; manage partnerships to achieve impact
Serve as a leadership partner and technical resource to grantees to achieve strategic objectives
Attend internal meetings to represent Clinical and Vaccine Development as well as being a representative of the foundation at external meetings
Active search for and create opportunities to develop new partnerships and between external partners that will advance GH programs
This role will require the ability to travel up to 30% domestically and internationally.
Your Experience
We are looking for people who enjoy the opportunity of working on complex projects and collaboratively creating solutions that have the potential for transformational change. We seek a self-starter who can integrate a diverse set of perspectives to build consensus, structure and drive forward progress on complex topics, and provide both strategic and operational capacity to the Vaccine Development team.
PhD and/or MD with 15+ years of experience work in one or more of the following areas: clinical research & development, vaccine development, infectious diseases and/or immunology
Experience in polio or other epidemic infectious diseases, and/or working with different vaccine platforms a plus
Industry experience as a project lead for a vaccine or biologics product
Experience developing and managing cross-functional product development plans
Extensive knowledge of clinical vaccine research from phase 1 through phase 4 including excellent statistical knowledge
Tolerance for ambiguity and ability to apply structure to simplify complex problems
An understanding of regulatory requirements necessary for various phases of vaccine and biologics development
Commitment to innovation and advancing new technologies in vaccine development
Intellectual quickness, curiosity, discipline, resourcefulness and resilience
Demonstrated ability to work with flexibility, efficiency, and enthusiasm in a fast-paced and complex internal and external environment
Experience working with partners in low and middle income countries
Experience with business and technical due diligence assessments of potential corporate, product or technology investments; ability to synthesize technical and commercial information towards strategic decision making
Strong judgment with a demonstrated ability to handle complex issues, multiple tasks, confidential information, and competing priorities with skill, discretion, a strong attention to detail, flexibility and diplomacy
Exceptional listening, verbal, and written communication skills, able to effectively calibrate input and synthesize information to connect with diverse audiences
Demonstrated experience in scientific writing and data analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience
Solid understanding of the realities and complexities of matrix-based organizations
Experience in working on teams with diverse culture and professional backgrounds
