Executive Director Regulatory, Medical, & CDU Solutions Partner

What you'll do

• Own the multi-year platform strategy and roadmap for Regulatory Affairs, Medical Affairs, and Clinical Data technology.
• Lead a team of Directors and Managers to deliver platform strategy, delivery governance, and compliant operations.
• Partner with senior business leadership to align technology capabilities with enterprise objectives and priorities.
• Manage the domain budget, financial forecasting, and vendor contract accountability for the platform portfolio.
• Establish governance frameworks, standards, and validation practices to ensure consistent platform delivery and vendor engagement.
• Oversee product backlogs, incident management, and release governance to ensure consistent reporting of delivered value.
• Ensure all platforms meet GxP validation, data integrity, and audit-readiness standards for global regulatory submissions.
• Represent technology priorities in enterprise architecture forums to align platform investments with corporate security and standards.

What we're looking for

• Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field.
• Master’s degree (preferred).
• 15+ years of progressive industry or relevant professional experience.
• Significant experience managing enterprise-scale regulatory, medical affairs, or clinical data technology platforms.
• Experience in the biotech, pharma, or life sciences industry (preferred).
• Proven experience leading a multi-disciplinary team of Directors and Managers, including budget and vendor contract accountability.
• Deep expertise in regulatory information management and medical affairs systems, such as Veeva RIM or Veeva Vault.
• Experience with clinical data, precision medicine technology, GxP validation practices, and PMP or ITIL certifications (preferred).