The Senior Director, GPS Business Solution Lead will serve as the key interface between GPS business leadership and Digital & Technology, orchestrating D&T capabilities to deliver on Regeneron's Global Patient Safety (GPS) objectives and priorities across platforms, including Argus (safety), PIVIT, Signal Management, aRMM/ARMM, and SRP. This role owns the platform strategy and roadmap, prioritizing investment in partnership with the business, and will lead a team of Directors delivering delivery governance and regulatory-compliant operations across the safety technology portfolio. The Business Solution Lead will partner closely with GPS business leadership, Enterprise IT, and Information Security to ensure safety systems support Regeneron's Global Patient Safety obligations and global regulatory commitments.

This role reports to the Executive Director, Global Development IT and will collaborate closely with GPS business leadership and Enterprise IT partners to shape the safety technology roadmap and ensure delivery excellence across the platform portfolio.

Where and When

This is an on-site position 4 days/week, primarily based at our Sleepy Hollow, NY or Warren, NJ office. If eligible, we can offer relocation benefits; we cannot offer a fully remote option.

Key Responsibilities

In this role, you will own platform strategy and delivery for Regeneron's Global Patient Safety technology portfolio, leading a team of Directors across the domain. Your day-to-day responsibilities will include:

GPS Platform Strategy & Ownership

• Partner with senior GPS leadership, to align technology and capabilities to deliver on Global Patient Safety objectives and enterprise priorities.

• Own and prioritize, in partnership with the business, the multi-year platform strategy and roadmap for Argus (safety), PIVIT, Signal Management, aRMM/ARMM, and SRP, translating Global Patient Safety and regulatory priorities into a funded, prioritized delivery plan.

• Own the organizational design of the GPS Business Solution function, including structure, role allocation, and resourcing across Directors and Managers assigned to the domain.

• Establish governance frameworks, standards, and validation practices for GPS platform delivery, ensuring consistency across teams and vendor engagements.

• Own budget, forecast, and vendor contract accountability for the GPS platform portfolio, including software licensing and services agreements.

Delivery Oversight & Team Leadership

• Serve as the escalation and quality-assurance point for planning, prioritization, and execution of safety platform initiatives led by direct reports.

• Oversee product backlog, incident management, and release governance across the GPS platform portfolio, ensuring consistent reporting of value delivered against plan.

• Coach and develop Directors and Managers, ensuring delivery commitments are met and domain capabilities continue to mature.

• Manage steering committee meetings, working groups, and issue/release management for upgrades to existing safety platforms.

Data Governance & Regulatory Compliance

• Partner with GPS business leadership, Regulatory Affairs, and Quality organizations to ensure safety platforms meet GxP validation, data integrity, and audit-readiness standards.

• Own data classification, access, and quality standards for safety-related data, ensuring compliance with global safety reporting obligations (e.g., FDA, EMA).

• Maintain oversight of case processing, signal detection, and risk management workflows to ensure platforms support timely and accurate regulatory reporting.

Cross-Functional & Vendor Partnership

• Partner with Enterprise IT, Enterprise Architecture, and Information Security to align safety platform investments with enterprise standards and security requirements.

• Build and maintain relationships with key platform vendors to clarify demands, resolve conflicts, and align technology roadmaps to business needs.

• Represent GPS technology priorities in enterprise architecture and governance forums, ensuring alignment with enterprise-wide standards.

Executive & Stakeholder Engagement

• Serve as the primary point of contact for senior GPS and IT leadership on matters requiring negotiation of complex or ambiguous issues.

• Build relationships with key GPS business leaders to clarify demands, resolve conflicts, and align technology roadmaps with pharmacovigilance priorities.

• Monitor industry trends in drug safety technology and regulatory reporting, bringing forward innovative approaches to senior leadership.

• Prepare and deliver executive-level materials on the health and roadmap of the GPS platform portfolio for governance forums and senior leadership.

Qualifications and Requirements

Education & Experience

• Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field (Master’s degree preferred).

• 15+ years of progressive industry/relevant professional experience, including significant experience managing enterprise-scale Global Patient Safety, drug safety, or regulatory technology platforms.

• Experience in the biotech, pharma, or life sciences industry strongly preferred.

• Proven experience leading a multi-disciplinary team of Directors and Managers, including budget and vendor contract accountability for a major function.

Technical Expertise

• Deep expertise in patient safety and drug safety systems (e.g., Oracle Argus Safety, signal management, and risk management platforms).

• Experience with global safety reporting standards and regulatory requirements (e.g., E2B, ICSR, FDA, EMA).

• Strong knowledge of GxP validation practices and solution delivery life cycle management.

• Experience managing technology capability identification, selection, and implementation across multiple simultaneous safety platform initiatives.

Skills & Competencies

• Proven track record of budget and vendor management for a department or major function.

• Strong stakeholder management and negotiation skills, with experience influencing senior management internally and externally.

• Demonstrated ability to grow, motivate, and develop teams, coaching Directors and Managers through career milestones and progression.

• Strategic mindset with the ability to define organizational structure and set long-term goals and objectives for a major function.

• Exceptional executive communication skills, with experience engaging senior/executive leadership on sensitive or ambiguous matters.

Certifications (Preferred)

• PMP or equivalent project/program management certification.

• ITIL or SAFe Agile certification.

Salary Range (annually)