Director, Digital Standards Strategy – Regulatory Science

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Define the scientific framework that governs USP’s Digital Standards, encompassing scientific principles, structural components, rigor requirements, and a lifecycle approach.

• Convert the Digital Standards framework into enterprise strategy and operational models across various USP divisions.

• Supervise lifecycle governance and ensure scientific rigor aligns with traditional USP Standards.

• Establish and enhance cross-functional governance, including decision rights, portfolio prioritization, metrics, and escalation processes.

• Provide updates, options, and recommendations to the Digital Standards steering committee and senior stakeholders.

• Develop and implement strategies for engagement with regulators, government entities, and industry.

• Form scientific and policy partnerships and design pilots and collaboration agreements.

• Lead external relations with regulators, government agencies, standards organizations, scientific societies, and pharmaceutical manufacturers.

• Represent USP as a thought leader at conferences, through publications, and in industry forums.

• Oversee the policy frameworks for Digital Standards and translate policies into schemas, specifications, guidance, training, and playbooks.

• Coordinate alignment across divisions regarding quality, security, legal, and commercial governance.

• Manage portfolio strategy, implementation plans, budgets, forecasts, and KPIs for the Digital Standards Business Unit.

• Prioritize the development of compendial Digital Standards and Digital Emerging Standards.

• Build, lead, and nurture a multidisciplinary team focused on advocacy, collaborations, scientific development, policy, and program management.

• Provide functional oversight for digital products, including USP-ID and MethodConnect.

• Mentor and develop leaders, establish performance management practices, and cultivate an inclusive culture.

• Establish planning, portfolio review, KPI dashboards, and communication rhythms with stakeholders.

⛳️ Requirements

• 10+ years of progressive experience in pharmaceutical sciences, analytical chemistry, regulatory science, or a closely related scientific field.

• Proven scientific credibility recognized by peers in the industry, regulatory bodies, or standards organizations.

• 7+ years of experience in people management.

• Experience in building multidisciplinary teams across advocacy, scientific, policy, and program functions.

• Capability to implement change within a matrixed organization.

• Ability to influence senior stakeholders and shape governance, operating models, workflows, and policy frameworks.

• Proficiency in convening and aligning regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a common scientific or policy framework.

• Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific, pharmaceutical, or analytical discipline, or a comparable history of peer-reviewed publications, contributions to public standards, or recognized leadership in scientific/regulatory working groups.

• Experience within a regulatory or standards-setting organization such as FDA, EMA, or ICH.

• Understanding of pharmacopeial standard-setting processes and the pharmaceutical product development and quality control landscape.

• Familiarity with scientific content workflows, analytical methods, and/or digital method lifecycle frameworks.

• Experience with analytical chemistry technologies such as NMR, FTIR, MassSpec, and HPLC.

• Proven track record in establishing strategic collaborations and drafting agreements with pharmaceutical or life-science organizations.

• Strong strategic thinking, negotiation, communication, and stakeholder engagement abilities.

• Comfort in navigating ambiguity in a rapidly evolving domain.

🏝️ Benefits

• Company-paid time off.

• Comprehensive healthcare options.

• Retirement savings plans.

• Equitable access to mentorship, professional development, and leadership opportunities.

• Training in equitable management practices and tools.

• Reasonable accommodations for individuals with disabilities.

• An inclusive and collaborative work environment.

• Target Annual Bonus: percentage varies based on the level of the role.