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

• Strategic Integration
• 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.

• Cross-Functional Leadership
• 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.

• Center of Excellence Development
• 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.

• Product and Partnership Strategy
• Evaluate digital health technologies and partners through a regulatory and commercial lens.
• Guide product architecture and build-versus-partner decisions to ensure pathway readiness.

• External Engagement and Thought Leadership
• 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

• Basic 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.

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

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Physical/Mental Requirements

Extensive computer use

Non-standard Work Schedule, Travel Or Environment Requirements

• Travel may be required as part of this role. Expectations around travel will vary but candidates must be capable of travel within the region, to other regions, and to Pfizer World Headquarters.
• Pfizer Digital is a 7x24x365 endeavor. This role may require physical or virtual participation on a weekend, holiday, or after normal business hours