Deputy Director, Clinical Next Generation Vaccines, Vaccine Development & Surveillance, Seattle, WA, United States 8 views

Group Summary

Our 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 proven 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, biologics, 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. Our work in maternal, neonatal and child health focuses on ensuring that women and newborns survive and remain healthy before, during and after childbirth, and ensuring optimal growth, neurodevelopment and resistance to disease, by identifying and addressing underlying biological vulnerabilities. We also support innovative research in reproductive health. These strategies are supported by functional teams that focus on Discovery & Translational Sciences, Vaccine Development & Surveillance, and Integrated Development.

Team Summary

The goal of the Vaccine Development & Surveillance Team is to advance public goods for global health through technological innovation. We do this by accelerating the development and commercialization of novel vaccines and the sustainable manufacture of existing vaccines, defining the global disease burden through better primary data and world-class modeling, and reducing the threat of epidemics through the development and use of innovative tools.

Position Summary & Responsibilities

As a key member of the Vaccine Development team, the Deputy Director, Next Generation Vaccines, is accountable for leading the foundation’s investments and partnerships on priority product development efforts. These consists of several ‘next generation’, innovative vaccines expected to deliver high-impact in the near term, including novel OPV, IPV, Hexavalent vaccines, and measles-rubella microarray patches (MR MAPS) as well as vaccines developed on new platforms. You will provide clinical leadership, program management, strategy development and communications on Vaccine Development & Surveillance priorities, Product Development Partners, and other foundation partners. You will also partner closely with the Deputy Director (DD), Integrated Clinical Development, and 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

This person will lead the Clinical, Next-Gen Vaccines team and report to the Director of Vaccine Development & Surveillance

Core responsibilities

Define strategy for and lead the Clinical, Next-Gen Vaccine domain area.

Partner closely with team leadership, including the team Director, DD Integrated Clinical Vaccines Development, DD CMC Vaccine Development and DD Vaccine Regulatory, to communicate and implement the overall Vaccine Development strategy.

Drive comprehensive product development strategy for the development of nOPV, IPV, IPV-containing Hexavalent vaccine, and MR MAPS including acting as foundation voice in global consortia related to product development

Partner closely with the foundation Polio and Global Delivery Programs to ensure end-to-end program alignment and coordination

Represent foundation on working groups with WHO, GPEI and other major partners on key product development priorities

Act as foundation ‘Project Lead’ and integrator 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.

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

This role will require the ability to travel up to 30% domestically and internationally

Leadership and Culture

We believe that energized people, working well together, fueled by great leadership in an inclusive environment in which they thrive, will do phenomenal things.

Core Knowledge and 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 technical and operational capacity to the Vaccine Development & Surveillance portfolio. We are looking for individuals with:

PhD and/or MD with 15+ years of experience working in one or more of the following areas: clinical research & development, vaccine development, infectious diseases and/or immunology

Tags

child health

data analysis

development plans

global health

infectious diseases

malaria

manufacturing

medical devices

neglected tropical diseases

oral communication

polio

product development

public goods

research and development

translation

tropical diseases

vaccine development

Experience in polio or other traditional infectious diseases (e.g. meningitis, yellow fever), and/or working with different vaccine platforms a plus

Industry experience at a senior level as a cross-functional project lead for vaccine or biologics product development

Experience developing and managing against cross-functional product development plans

Extensive knowledge of clinical vaccine development from phase 1 through phase 4 including excellent statistical knowledge

Significant knowledge of vaccines including major challenges in development

Extensive knowledge of biopharma/pharma industry best practices for program management

Demonstrated ability to learn new disease areas and new vaccine technologies quickly.

Experience working with medical devices or combination products a plus

Demonstrated ability to lead and affect data-driven strategy planning and implementation

Demonstrated excellence in scientific writing and data analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience.

Demonstrated ability to work with flexibility, efficiency, and enthusiasm in a fast-paced and complex internal and external environment

Proven program and stakeholder management skills: ability to coordinate inputs from many people; to track progress against targets and identify barriers to progress; to plan agendas and facilitate meetings; and to organize, evaluate, and communicate information

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.

Tolerance for ambiguity and ability to apply structure to simplify complex problems

Intellectual quickness, curiosity, discipline, resourcefulness and resilience.

Exceptional listening, verbal, and written communication skills, able to effectively calibrate input and synthesize information to connect with diverse audiences

Excellent interpersonal and diplomatic skills. You must possess excellent relationship management skills to develop trusting and productive relationships with a wide range of

colleagues, dignitaries, leaders, grantees, consultants and other partners. Experience working with international groups (WHO, GPEI, GAVI, UNICEF) and/or in developing world settings, as well as knowledge of global regulatory standards (WHO PQ) a plus

Demonstrated passion for the Foundation’s values with a commitment to deliver results against our mission

As part of our standard hiring process for new employees, employment with the Bill and Melinda Gates Foundation will be contingent upon successful completion of a background check.

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.

All applicants and employees who are drawn to serve the mission of the Bill & Melinda Gates Foundation 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

* Prior Protected Activity

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