Senior Director, Digital Medicine & PDURS Strategy Lead

Role Summary

This role will translate deep prescription drug use-related software (PDURS) regulatory expertise and digital health commercialization experience into product design, clinical strategy, and commercial execution for digital medicine programs while building cross-functional capabilities and supporting the establishment of a PDURS Center of Excellence. This newly created role bridges PDURS regulatory expertise with digital medicine product and commercialization strategy across the organization’s digital medicine portfolio. The position will guide cross-functional teams to design, validate, and launch drug-digital solutions that meet regulatory requirements, achieve clinical impact, and deliver commercial value. The Digital Medicine & PDURS Strategy Lead will serve as the organization’s primary strategist for PDURS-enabled programs, embedding regulatory and market insight into product development, clinical trial design, and business decisions across the drug portfolio. The successful candidate will bring a unique blend of hands-on digital health commercialization experience and a deep understanding of how digital technologies have navigated FDA pathways, enabling scalable innovation within and beyond cardiometabolic disease.

Responsibilities

• Translate PDURS and digital medicine regulatory requirements into product, clinical, and commercial strategies.
• Serve as principal advisor to brand, medical, and commercial teams on drug-digital integration.
• Identify therapeutic opportunities where digital components enhance outcomes or market performance.
• Bridge regulatory, R&D, clinical, commercial, and policy workstreams to deliver cohesive execution of digital medicine programs and ensure enterprise alignment.
• Work in support of the regulatory team to develop FDA engagement strategies while integrating policy and market perspectives to shape overall program direction.
• Facilitate collaboration across teams to align objectives, investment decisions, and timelines for digital medicine initiatives that span regulatory, clinical, and policy domains.
• Build institutional knowledge through frameworks, best practices, and training.
• Leverage cardiometabolic disease as the foundation for scalable PDURS implementation across therapeutic areas.
• Champion PDURS initiatives with senior leadership.
• Evaluate digital health technologies and partners through a regulatory and commercial lens.
• Guide product architecture and build-versus-partner decisions to ensure pathway readiness.
• Engage regulators, policy makers, and industry groups to shape the evolving PDURS regulatory landscape and advance digital medicine policy.
• Represent the organization publicly on digital medicine and PDURS strategy through advocacy, publications, and presentations.

Qualifications

• PhD, MD, or advanced degree in biomedical engineering, translational medicine, health technology innovation, or a related field.
• 7+ years combining digital health regulatory expertise with commercialization strategy.
• Deep knowledge of PDURS frameworks and digital-drug regulatory integration.
• Experience supporting pharmaceutical digital health programs (companion apps, connected devices, wearables, etc.).
• Track record of engagement with FDA and cross-functional leadership in pharma.
• Recognized thought leader with digital health publications, presentations, or policy contributions.

Skills

• Direct PDURS program design, FDA submissions, or advisory experience (preferred).
• Leadership in industry associations or working groups shaping PDURS or digital medicine policy (preferred).
• Experience across multiple therapeutic areas and international markets (preferred).

Education

• As listed in Basic Qualifications.

Additional Requirements

• Travel may be required as part of this role.
• Pfizer Digital is a 7x24x365 endeavor; role may require participation outside normal hours.