Deputy Director, Regulatory Affairs, Global Health

22 Apr, 2020

Jobs

Deputy Director, Regulatory Affairs, Global Health

Gates Foundation
Seattle, WA

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 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 – Discovery and Tools. These strategies are supported by functional & cross cutting teams that focus on Discovery and Translational Sciences, Innovative Technology Solutions, Vaccine Development, and Innovation Introduction, and Integrated Development.

Position Summary & Responsibilities

The Integrated Team is looking for an exceptional Deputy Director (DD) who will drive the regulatory strategy and execution plans for product development related grants and investments. You will be accountable to seek alignment with the Foundation’s goals and priorities, and optimize the regulatory strategy to be efficient and timely with respect to development, registration, country introduction, and post-licensure stewardship of the Foundation’s global health tools. Product scope includes vaccines, medicines, biologics, medical devices and diagnostics.

The Deputy Director, Regulatory Affairs (DDRA) will support Global Health program strategy and/or functional teams and be responsible for:

  • Providing internal program strategy teams (PST) with product specific regulatory support from discovery to delivery for vaccines, biologics, pharmaceuticals, medical devices and diagnostics, and occasionally vector control tools.

  • Advising and working closely with the PSTs and grantees to align on efficient and innovative regulatory strategies to facilitate and expedite product development and optimize the probability of success for regulatory approval at the originator and destination countries and WHO Prequalification (PQ).

  • Providing grantees with support on strategy, tactics, and external resources (CROs, consultants) as needed to facilitate timely clinical trial authorizations and product registrations.

  • Advising grantees on optimal strategies and tactics for timely WHO PQ and pathways for Low- and Middle-Income Countries (LMIC) registration, including strategies for leveraging global health regulatory systems initiatives aimed at facilitating registration and access in LMIC (e.g. the WHO Collaborative Registration Procedure and regional regulatory harmonization initiatives).

  • This role is responsible for high quality interactions and clear and consistent communications with grantees and partners in the field.

  • Has financial responsibility for either grant making and/or operating budget as determined under Delegation of Authority

Reports to: Director, Integrated Development

Leadership & Culture

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

Core Knowledge & Skills

Experience with product development, registration and regulatory life-cycle management ideally with some experience in LMICs. Some experience with products targeting global infectious diseases including pharmacology/pharmacokinetics/immunology is preferable. Knowledge of major industrialized country regulatory processes and considerations, FDA, EMA, and WHO PQ.  Experience with other developed and developing nations (e.g. national regulatory authorities in the EU, Canada, Australia, India, China, and South Africa) is preferred.

The ideal candidate will have strong management capabilities and will have managed a diverse portfolio of products with the ability to demonstrate following:

  • Decision-Making:

    • Determine scope and nature of regulatory technical contribution to PSTs, presentations to internal and external customers, leadership briefings, etc.

    • Select initiatives and potential grantees in alignment with foundation strategy and objectives

    • Staffing recruitment and management

  • Internal & External Contacts:

    • Internally with Global Health Leadership (Senior Program officers, Deputy Directors, Directors, Presidents), ad hoc with CEO, Co-Chair

    • Externally with Heads and leadership of National Regulatory Agencies, WHO ADGs and Directors, Donor groups Directors, Pharma industry senior leadership, African Union agencies Director/Commissioner levels, etc.

    • Skills- technical excellence, common appreciation of the problem at hand, humility, negotiation skills, listening, bottom up approach to collaboration, cultural sensitivity, firmness

  • Problem Solving:

    • Problems are highly complex; decisions are made only after extensive research and consultation with others

Education:

  • M.D. or PhD with 11+ years of experience in product development experience in Pharma/Biotech and /or Life science companies

Additional skills/experience:

  • Demonstrated ability to lead people and teams to effectively achieve clear, yet complex goals and objectives.

  • Strong experience in working effectively with senior decision makers as it pertains to strategy development and operations.

  • Demonstrated ability in portfolio design and management to create optimal investment mix to work towards a set of outcomes.

  • Experience developing and handling strong partnerships and relationships both inside and outside the organization, handling conflicts, and building consensus.

  • Ability to lead and influence data-driven strategy planning and implementation.

  • Effective collaborator and experience working in a matrix environment (i.e., ability to influence without formal authority).

  • Shown strength in structured problem solving and strategic business planning, with the ability to easily identify and communicate frameworks to analyze issues and synthesize disparate information.

  • Adept at project management; including critical path thinking, detail orientation, setting priorities, and planning.

  • Broad knowledge of global health issues, product development processes and regulatory requirements and procedures; at both global and national levels is helpful.

  • Strong technical and financial knowledge; including the ability to communicate data and results to inform sound strategic and tactical decisions. Experience developing, evaluating, managing, and monitoring business plans, budgets and financial reports.

  • Intellectual quickness, curiosity, discipline, resourcefulness and resilience combined with a good sense of humor.

  • High level of cultural competence

  • Ability to travel up to 30% domestically and internationally.

  • Passion for the Foundation’s values with a commitment to deliver results against the Foundation’s 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

Learn more here

Job posted: 2020-04-22