Director, Digital Standards Strategy and Regulatory Science

USP•Rockville, MD

2d•Hybrid

About The Position

The U.S. Pharmacopeial Convention (USP) is seeking a scientific and regulatory leader for its Digital Standards Business Unit. This role is accountable for defining the scientific framework for USP’s digital pharmacopeial standards and building the coalition of regulators, government stakeholders, and industry partners required to champion and adopt it. Success in Year 1 will include establishing the scientific principles, policy foundations, and workflows that govern how USP develops and delivers Digital Standards, securing internal alignment, and building engagement with regulators, standards bodies, and pharmaceutical manufacturers to align the field behind that framework. This individual will represent USP in high-stakes external scientific and regulatory forums and serve as a visible thought leader on the future of digital pharmacopeial quality standards. Internally, the Director will work highly cross-functionally with USP’s Science, Quality, Lab Operations, IT, Commercial, and other teams to ensure Digital Standards are embedded in USP’s compendial and commercial processes. The Director will also have functional oversight of the portfolio of Digital Standards products, including USP-ID and MethodConnect, ensuring product direction aligns to the scientific framework. Scale-up and market adoption are priorities in subsequent years that will follow framework and stakeholder alignment. This role requires skills in both internal change management and external stakeholder alignment within the scientific realm.

Requirements

10+ years of progressive experience in pharmaceutical sciences, analytical chemistry, regulatory science, or a closely related scientific discipline, with demonstrated scientific credibility recognized by peers in industry, regulators, or standards bodies.
7+ years of people management experience, including building multi-disciplinary teams across advocacy, scientific, policy, and program functions.
Proven ability to implement changes across a matrixed organization, including influencing senior stakeholders, and shaping governance, operating models, workflows, and policy frameworks.
Demonstrated ability to convene and align regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a shared scientific or policy framework.
Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific, pharmaceutical, or analytical discipline, OR a comparable track record of peer-reviewed publications, contributions to public standards development, or recognized leadership in scientific or regulatory working groups.

Nice To Haves

Experience within a regulatory or standard setting body, like FDA, EMA, ICH
Understanding of pharmacopeial standard setting process and its relevance in pharmaceutical product development and quality control
Experience with scientific content workflows and analytical methods and/or digital method lifecycle frameworks.
Experience with analytical chemistry technologies, including NMR, FTIR, MassSpec, HPLC, and others.
Experience with establishing strategic collaborations, including drafting agreements with pharmaceutical or other life science organizations.
Strong strategic thinking, negotiation, communication, and stakeholder engagement skills; comfort operating with ambiguity in a fast-evolving domain.

Responsibilities

Define the scientific framework governing USP’s Digital Standards including scientific principles, structure, rigor requirements, and lifecycle approach, in close collaboration with USP’s Science and Quality teams, and translate that framework into the enterprise strategy and operating model required to scale Digital Standards across USP divisions.
Oversee Digital Standards lifecycle governance, ensuring scientific rigor on par with traditional USP Standards and consistent application of the scientific framework across product lines.
Ensure Digital Standards integrate with and support USP documentary standards and scientific development processes as the enterprise evolves.
Establish and continuously improve cross-functional governance (decision rights, portfolio prioritization, metrics, escalation) to balance speed, rigor, and compliance.
Provide executive-level updates, options, and recommendations to the Digital Standards steering committee and senior stakeholders.
Own development and execution of the regulator, government, and industry engagement strategy required to build alignment and cultivate champions for the scientific framework across the pharmaceutical ecosystem.
Develop and oversee scientific and policy partnerships; collaborate with Legal department and other enterprise stakeholders to structure pilots and collaboration agreements with regulators, standards bodies, and pharmaceutical manufacturers.
Lead high-stakes external engagement with regulators, government agencies, standards bodies, scientific societies, and pharmaceutical manufacturers to align the field behind USP’s Digital Standards scientific framework and cultivate external champions.
Represent USP as a thought leader through conferences, publications, and industry forums; maintain relationships with key scientific, regulatory, and industry influencers.
Oversee internal and external policy frameworks for Digital Standards (structure, lifecycle, metadata, interoperability, implementation guidance) and ensure consistency across product lines.
Ensure policy is translated into practical implementation assets (schemas/specifications, guidance, training, playbooks) for industry and internal stakeholders.
Coordinate cross-division alignment so Digital Standards policies fit within enterprise controls (quality systems, security, legal, and commercial governance).
Oversee portfolio-level strategic alignment, implementation plans, annual budgets, forecasts, and KPIs for Digital Standards Business Unit.
Translate market insights and performance analytics into portfolio choices.
Prioritize development of the portfolio of compendial Digital Standards and Digital Emerging Standards.
Build, lead, and develop a multi-disciplinary team spanning advocacy, strategic collaborations, scientific development, policy, and program management.
Provide functional oversight for the portfolio of digital products relating to Digital Standards to ensure alignment of product development with scientific, regulatory, and policy approaches.
Coach and develop leaders; set clear expectations and equitable performance management practices; foster an inclusive culture that supports growth and accountability.
Establish scalable operating rhythms (quarterly planning, portfolio reviews, KPI dashboards, stakeholder communications) that enable predictable delivery and learning.
Be a visible influencer for Digital Standards both internally and externally; facilitate information sharing and thought leadership through publications, presentations, discussions, and other fora.