Senior Director: Global Patient Safety Solutions Partner

Key Responsibilities

• Partner with senior GPS leadership to align technology and capabilities to deliver on Global Patient Safety objectives and enterprise priorities.
• Own and prioritize the multi-year platform strategy and roadmap for Argus (safety), PIVIT, Signal Management, aRMM/ARMM, and SRP.
• Own the organizational design of the GPS Business Solution function, including structure, role allocation, and resourcing.
• Establish governance frameworks, standards, and validation practices for GPS platform delivery.
• Own budget, forecast, and vendor contract accountability for the GPS platform portfolio.
• Serve as the escalation and quality-assurance point for planning, prioritization, and execution of safety platform initiatives.
• Oversee product backlog, incident management, and release governance across the GPS platform portfolio.
• Coach and develop Directors and Managers, ensuring delivery commitments are met.
• Manage steering committee meetings, working groups, and issue/release management for upgrades to existing safety platforms.
• 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.
• Partner with Enterprise IT, Enterprise Architecture, and Information Security to align safety platform investments with enterprise standards.
• 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.
• Serve as the primary point of contact for senior GPS and IT leadership on matters requiring negotiation of complex or ambiguous issues.
• 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.

Qualifications and Requirements

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.

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.

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.