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Seattle, WA Full Time Posted by: Bill & Melinda Gates Foundation Posted: Sunday, 22 November 2020
 
 

The IDev Regulatory Affairs team is looking for an outstanding Senior Program Officer (SPO) who will support the systems aspects of our portfolio. The SPO will be responsible for:

Owning a portfolio of systems (product-agnostic) grants and investments focused on optimizing the regulatory systems through which quality health products must go through before they can be safely used. Our grantee partners are organizations working to promote global health as a priority issue, such as the World Health Organization, the African Union, Regional initiatives, and LMIC regulatory agencies. Work is done in close collaboration to ensure effective grants development and implementation and their integration into and coordination with the foundations overall global health strategies.

Playing a central role in determining the strategy for and implementing our Global 3S (Smart Safety Surveillance) initiative, a sub-portfolio of grants and investments focused on strengthening pharmacovigilance systems in LMICs, spanning partners across Africa, Asia, and the Americas. Pharmacovigilance is becoming a pressing concern as more products are being targeted directly to LMICs (or being launched in HIC and LMICs in parallel) and/or 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.

Partnering with our PSTs on regulatory initiatives that are part of their strategies but managed by IDev. Examples include working with our Malaria PST and grantees to build novel regulatory pathways for emerging gene technologies in Africa - working across multiple sectors such as agricultural, environmental, biosafety, and health regulators, as well as ethicists, to build a wholistic approach to regulation of these types of products.

Collaborating with Regulatory team members who are responsible for developing product-specific strategies to ensure that the systems changes being catalyzed in these LMIC regulatory and safety pathways are being fully leveraged by our product development grantees to accelerate access to quality health products.

This role is responsible for high quality interactions, and clear and consistent communications with internal teams, grantees, and external partners.

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

Reports to: Deputy Director, Regulatory Affairs, Integrated Development. The role will be based out of Seattle, WA, or Washington, D.C., as a Limited Term Employee (LTE) for 12 months, with the possibility of extension.

Leadership & Culture

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

Core Knowledge & Skills

Experience with product development, registration, and regulatory life-cycle management, including ideally 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 (eg FDA, EMA, and WHO PQ). Experience with other developed and developing countries' national regulatory authorities (eg Australia, India, China, and South Africa) is preferred.

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

Decision-Making:

Strong experience in working effectively with senior decision makers to influence data-driven strategy development and operations.

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

Effective collaborator and experience working in a Matrix environment (ie, ability to influence without formal authority).

Internal & External Contacts:

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

Internally with Global Health Leadership (POs, SPOs, Deputy Directors, Directors), ad hoc with President, CEO, Co-Chairs

Externally with Heads and leadership of National Regulatory Agencies, WHO ADGs and Directors, Donor group Directors, Pharma industry senior leadership, African Union agencies Directors, etc.

Problem Solving:

Strength in structured decision-making, with the ability to easily identify and communicate frameworks to analyze issues and synthesize disparate information.

Problems are highly sophisticated; decisions are made only after extensive research and consultation with others.

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

Skills:

Technical excellence, common appreciation of the problem at hand, humility, negotiation skills, listening, bottom up approach to collaboration, cultural competence, firmness.

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

A passion for the Foundation's values with a dedication to deliver results against the Foundation's mission.

Education and Work Experience:

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

This could be gained from 7+ years of experience in product development within Pharma/Biotech, a life sciences focus at Management Consulting firms, or in regulatory science at Regulatory Agencies and similar organizations.

M.D., PhD, MBA, or other graduate degree preferred.


Seattle, WA, United States of America
HR
Click apply
JS7750_7905450
11/22/2020 3:54:30 PM


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