Senior Director, Global Programs (Regulatory and Laboratory)

USP•Rockville, MD

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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; and lead the develop 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.
Other duties as assigned.