Senior Director, Technical Product Lead

ROLE SUMMARY

The DHM Technical Product Lead (TPL) leads the organization management design and delivery of regulated digital health products integrated with medicines and clinical development. You will own the endtoend product lifecyclefrom problem framing and roadmap to technical execution and postmarket evolutionpartnering across Engineering Clinical/Medical Regulatory Quality and external technology vendors. The ideal candidate combines deep technical product leadership with regulated-health experience (SaMD/NonSaMD/PDURS) ensuring solutions are secure scalable interoperable and inspectionready.

ROLE RESPONSIBILITIES

Product Vision & Roadmap

• Define and maintain a roadmap aligned with clinical strategy regulatory pathways (e.g. FDA 510(k) MDR ISO 13485) and business goals.
• Translate unmet needs of patients sites and study teams into clear problem statements outcomes and prioritized backlogs; ensure tight linkage to Integrated Product/Program Plans where relevant.

Technical Ownership

• Serve as products technical authoritydefining architecture patterns API contracts data models/flows integration with EHR/eCOA/wearables and telemetry/observability standards.
• Ensure reliability resiliency and scalability; drive secure SDLC practices privacybydesign and adherence to enterprise cloud standards.

Product Development and Leadership

• Lead crossfunctional squads (Engineering UX Data Science Clinical Ops QA) and orchestrate delivery using Agile product practices (OKRs dualtrack discovery/delivery release planning backlog health)
• Establish measurable outcomes and product KPIs (e.g. activation completion ePRO compliance device data yield incident rates study cycle time impact).

Regulatory & Compliance Integration

• Ensure adherence to IEC 62304 ISO 14971 and internal SOPs for software lifecycle and risk management.
• Collaborate with Regulatory Affairs to prepare documentation for FDA submissions MLR reviews and data privacy compliance (HIPAA/GDPR).

Technical Backlog Management

• Write and prioritize user stories including functional and non-functional requirements (security interoperability usability engineering).
• Manage technical enablers for architecture API integrations and cybersecurity controls.

Cross-Functional Collaboration

• Partner with Medical Affairs Clinical Legal and Security teams to ensure product decisions reflect patient safety and regulatory obligations.
• Coordinate with engineering and design teams for compliant implementation.

Risk & Quality Oversight

• Embed quality by design; ensure adherence to GxP HIPAA GDPR computer systems validation / CSV expectations and inspection readiness using the DHM lifecycle model and RQA audit strategy (SaMD & nonSaMD).
• Maintain risk registers (cybersecurity privacy reliability) change control release governance and traceability from requirements through verification/validation. Governance & Documentation
• Maintain traceability of requirements through SDLC artifacts and audit-ready documentation.
• Support vendor qualification for external software providers under MDR/ISO 13485.

Portfolio Governance & Financials

• Integrate product plans with portfolio governancepreparing clear options risks decision criteria and resourcing scenarios; manage budgets and forecasts across discovery through scale.

Stakeholder Engagement & Change Leadership

• Align and communicate with clinical operations regulatory medical commercial and digital leadership; craft executive ready materials and decision narratives; champion adoption across countries and functions.

BASIC QUALIFICATIONS

Education

• Bachelors or Masters in Computer Science Engineering Digital Health or related; MBA or advanced degree preferred.
  

Experience

• 12 years in product management/technical leadership with 5 in digital health pharma medtech or clinical tech.
• Demonstrated delivery of complex regulated digital products and/or software used in clinical trials (e.g. ePRO wearables remote monitoring PDURS) including vendor/CRO leadership.
  

Skills & Competencies

• Mastery of Agile product practices; proven ability to mentor squads and scale modern engineering/DevSecOps ways of working.
• Deep working knowledge of data privacy security validation and audit expectations across the DHM lifecycle.
• Exceptional stakeholder management and executive communication; can translate between technical clinical regulatory and business audiences.

PREFERRED QUALIFICATIONS

• Familiarity with AI/ML in healthcare (e.g. signal processing risk prediction personalization) and its regulatory considerations.
• Experience contributing to software related labeling or PDURS strategies; FDA interactions or submissions a plus.
• Background in patient centric design and usability testing in trial settings.

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

Work Location Assignment:On Premise

Last Date to Apply for Job: 11/26/2025

Relocation assistance may be available based on business needs and/or eligibility.