The U.S. Pharmacopeial Convention (USP) Director, External Scientific Collaboration- Biologics in Rockville, Maryland
Director, External Scientific Collaboration- Biologics
The Director, External Scientific Collaboration, Biologics is a critical role to help foster USP global scientific leadership in standards setting for biologics. The incumbent will be responsible of enhancing USP’s visibility and enhancing our stakeholder engagement. The incumbent will also play a key role within USP’s science division team in developing and implementing strategies for advocacy for the importance and role of standards to ensure the quality of biological medicines. The individual will be part of the global science biologics leadership team and will lead a team of senior scientific staff that supports the development of scientific publications, training and education programs, and nurtures external scientific collaborations.
Roles and Responsibilities
Develops and leads strategies to enhance visibility of the USP biologics program within a variety of stakeholders including national and international regulatory agencies, associations and other organizations that focus on facilitating access to biological medicines
Develops key partnerships with leading scientific research organizations in academia and industry as well as other stakeholders including funding, regulatory, and disease control agencies, and payer communities.
Leverage USP’s longstanding role in providing quality standards for medicines, and develop workplans to cultivate these relationships.
Conducts research and landscape analysis to support positioning the role of quality standards for biological medicines. Design and engage studies to explore the impact of standards on access to biotherapeutics.
Identifies opportunities for USP to position its scientific approaches as key elements of policy discussions affecting the quality of biopharmaceuticals.
Represents USP in key scientific, regulatory and policy events.
Drives execution of a plan for publication of USP’s scientific data with a goal to contribute to solve key quality issues within the biopharmaceutical industry
Contributes to the biologics program unit annual planning and supports the development of a pipeline for education, trainings, workshops and related programs.
Collaborates with the strategic marketing team, analyzes market and regulatory trends and considers stakeholders’ insight to expand the biologics educational and trainings offerings.
Influences key opinion leaders by executing the biologics program strategy for peer-review publications, blogs, op-eds, etc. Communicates the findings to the broader biologics and biosimilar communities.
Prepares program reports for internal and external stakeholders. Designs and tracks metrics related to deliverables of scientific leadership programs.
Doctoral level degree in a relevant discipline (MD, PharmD, PhD, health sciences) with a minimum of 10 years of experience in a scientific collaboration function with impact on regulatory and health policy outcomes and decisions. Minimum of 4 years of experience supervising, leading teams, training, or mentoring of other staff members, including scientific staff.
Strong Knowledge of the global regulatory requirements for biotherapeutics
Knowledge of the scientific literature applicable to development and market access for biotherapeutics
Demonstrated interest in conducting research, publications and experience in tracking impact of the research
Excellent publications record on issues that relate to biologics and biosimilars.
Critical thinking and ability to evaluate own research findings as well as research by others
Demonstrated leadership in managing internal and external relationships and building teams
Experience working globally with diverse groups including scientists, manufacturers, associations, healthcare providers and policy makers
Strong ability to leverage key external partnerships and facilitate execution and publication of scientific collaborations consensus
Track record of high performance and results-oriented approaches.
Travel may be required for some of the internal and external business meetings.
Senior scientific staff (2-4)
USP offers an impressive benefits package , including:
Generous paid time off – 14 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Rockville, Maryland, United States
Job Category Scientific