Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Role Summary

The Associate Director, IT Regulatory, Clinical and Enterprise Systems leads efforts to enable digital processes across Clinical Operations, Regulatory, Planning, and Enterprise Systems to support RayzeBio's commercialization objectives. Reports to the Executive Director, IT and manages the digital systems roadmap, budgets, and partnerships with IT and business stakeholders. Focus is on delivering scalable digital solutions for regulatory and clinical operations, integrated with large corporate and small biotech systems.

Responsibilities

• Accountable for continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply Chain planning and related Enterprise Systems, including clinical site portal, RIM, supply chain planning, and other regulated functional solutions and associated infrastructure.
• Deliver on service level management with IT groups and vendor services, including SLAs, disaster recovery, and business continuity.
• Ensure Digital Roadmap is leveraged and aligned to business outcomes; drive value realization.
• Lead a group of indirect reports and service providers to deliver effective, innovative, and stable solutions.
• Partner with functional leaders to develop and align strategies for business process improvements through information systems automation.
• Provide IT leadership to regulatory inspection readiness and data integrity initiatives.
• Ensure risk-based validation for the functions.
• Manage new demand and evolve digital solutions and mindset.
• Identify key technology trends and how innovative technologies can provide solutions.
• Participate in high-level strategic communications with the business and functional leadership teams.
• Develop long-term (3-year) roadmaps identifying capabilities with the greatest impact, benchmarking with external sources.

Education

• BS/MS Information Technology or similar degree or equivalent experience.

Qualifications

• 10+ years of IT experience in a cGMP injectable or Radiopharmaceutical environment.
• Proven technical leadership and management experience.
• Demonstrated experience implementing automation and digitization projects.

Skills

• Strong project management skills with a proven track record of leading multi-disciplinary teams in a regulated environment.
• Ability to influence stakeholders at all levels and drive strategic initiatives.
• Leads complex, multi-disciplinary projects including resource and budget allocation and operational leadership.
• Oversees deliverable product, sets vision and standards for work products, challenges teams.
• Ability to influence and build trust, maintain resilience in demanding situations, and encourage calm and rational behavior in teams.
• Identifies multiple solutions and recommendations for senior leaders; structures communications to achieve organizational goals and tailors content for stakeholders.
• Provides strategic feedback to vendors, synthesizes analyses to solve broader business issues, and represents the discipline on program/project teams.
• Identifies gaps in capabilities, enables development opportunities for colleagues, and drives functional direction with minimal guidance.

Additional Requirements

• Physical environment includes standard office plus GMP production/ facility environment; willingness to wear PPE as required.
• Comfortable working around radioactive materials.
• Periodic travel to other RayzeBio locations.