Senior Director, Global Programs (Regulatory and Laboratory)

Brief Job Overview

This role, a critical member of the Global Health and Manufacturing Services (GHMS) leadership team, is responsible for developing and implementing a global growth strategy for USP’s externally funded regulatory and laboratory programs. The incumbent will be primarily responsible for developing long-term strategic relationships with potential funders and partners which drive towards shaping and ultimate realization of new opportunities for programming in the United States and internationally. Additionally, she/he, will represent USP externally as a thought leader in a variety of forums and will supervise a global team across Africa and Asia.

Responsibilities

• Develop and continuously adjust USP’s growth strategy for regulatory and laboratory programming.
• Interface and partner with external and internal stakeholders, including potential funders, to understand evolving regulatory and laboratory technology landscape and customer needs.
• Align existing USP offerings and solutions to meet customer needs and develop new offerings in the regulatory and laboratory space to address gaps.
• Represent USP externally as a thought leader in technical discussions and in external forums to advance programming growth.
• Provide technical support and input to relevant funding proposals; lead the development of proposals with a primary focus on growing the regulatory and laboratory program.
• Manage and deploy global team to support growth strategy and implementation of secured programming.
• Support and / or oversee implementation of funded programming including providing strategic and technical oversight for specialized health systems programming, with a strong focus on regulatory strategies, strengthening National Regulatory Authorities (NRAs), pharmacovigilance (PV), post-market surveillance systems, and clinical study capacity for Bioequivalence/Bioavailability (BE/BA) trials.
• Be a thought partner to other leaders within the GHMS team as we collectively advance USP’s mission and broader strategic goals.

Qualifications

• Demonstrated understanding of USP’s mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Bachelor's or advanced degree in scientific, regulatory or related field.
• Minimum of five (5) years’ experience in regulatory role within or interfacing with stringent regulatory authority/authorities.
• Minimum of ten (10) years’ experience in Good Practice guidelines and regulations in pharmaceuticals and/or biologics (GxPs).
• Experience with/ understanding of WHO regulatory processes.
• Minimum of five (5) years in roles with international scope.
• Minimum of seven (7) to nine (9) years of people management experience.
• Proven track record of thought leadership as evidenced by speaking engagements/ panel roles and/ or publications/ other content generation.
• Willingness/ ability to travel at least 25% domestically and internationally.

Additional Desired Preferences

• Demonstrated ability to design, manage, and implement complex projects.
• Active network with potential funding sources / entities, including global (such as Gates, Global Fund) and domestic funders (such as Department of War, Health and Human Services, etc.).
• Experience and/or exposure with the changing landscape of regulatory and laboratory science as applied to new manufacturing and quality modalities (e.g., advanced manufacturing, AI-enabled processes, non-destructive testing).
• Relevant work experience in a lower middle income country (LMIC).
• Experience working in program / project management or other relevant technical area in DARPA, BARDA, JPEO-CBRAND or similar.

Benefits

• Compensation Base Salary Range: USD $208,060.00 – $262,150.00 annually.
• Target Annual Bonus: % Varies based on level of role.
• Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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