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Associate Director, IT Regulatory, Clinical, and Enterprise Systems
Bristol Myers Squibb. Implement RayzeBio’s vision for growth and lead efforts enabling digital processes for commercialization across Clinical Operations, Regulatory, Planning, and Enterprise Systems .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in IT leadership within a cGMP injectable or radiopharmaceutical environment, focusing on automation, digitization, and strategic project management. Proven ability to influence stakeholders, manage budgets, and drive business process improvements through innovative digital solutions.
Highest-signal resume keywords
10+ Years IT ExperienceTechnical LeadershipProject Management SkillsAutomation and Digitization ProjectsRegulatory Environment Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Digital Solutions ManagementOperational Solutions OversightService-Level ManagementRisk-Based ValidationAI Application in Decision-MakingBudget ManagementResource AllocationStakeholder InfluenceRegulatory Inspection ReadinessData Integrity Initiatives
Soft Skills
Influencing StakeholdersResilience in Demanding SituationsEncouraging Calm BehaviorTailored CommunicationStrategic Feedback Synthesis
Tools & Technologies
Clinical Site PortalRIMSupply Chain Planning SystemsVendor-Managed ServicesDisaster Recovery SolutionsEnterprise Systems
Industry Keywords
CGMPRadiopharmaceuticalsBiotech SystemsClinical OperationsRegulatory ComplianceInformation Systems Automation
About the role
Key responsibilities & impact- Implement RayzeBio’s vision for growth and lead efforts enabling digital processes for commercialization across Clinical Operations, Regulatory, Planning, and Enterprise Systems
- Ensure the digital systems roadmap is enabled and maintained to deliver novel radiopharmaceutical technologies
- Oversee operational solutions for regulatory and clinical operations, corporate systems, and biotech systems across assigned functions
- Set and manage budgets and collaborate with architectural, IT, and business partners
- Ensure continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply Chain Planning, and Enterprise Systems
- Manage clinical site portal, RIM, supply chain planning, regulated functional solutions, and associated infrastructure
- Deliver service-level management processes with IT groups and vendor-managed services, including SLAs and Disaster Recovery/Service Continuity
- Align the digital roadmap with business outcomes and drive value realization
- Lead indirect reports and service providers to deliver effective, innovative, and stable solutions
- Partner with functional leaders on business process improvements through information systems automation
- Provide IT leadership for regulatory inspection readiness and data integrity initiatives
- Ensure risk-based validation for supported functions
- Manage new demand and evolve digital solutions and mindset
- Identify technology trends and opportunities to leverage innovative technologies
- Participate in strategic communications with business and functional leadership teams
- Develop long-term three-year roadmaps identifying capabilities with the greatest business impact
- Apply AI to improve team execution and decision-making
- Travel periodically to other RayzeBio locations
Requirements
What you’ll need- 10+ years’ IT experience in a cGMP injectable or Radiopharmaceutical environment
- Proven technical leadership and management experience
- Demonstrated experience implementing automation and digitization projects
- BS/MS Information Technology or similar degree or equivalent experience
- 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
- Experience leading complex, multi-disciplinary projects including resource and budget allocation and operational leadership
- Experience overseeing deliverable products, setting vision and standards for work products, and challenging teams
- Strong influence and trust, resilience in demanding situations, and ability to encourage calm and rational behavior in teams
- Ability to identify multiple solutions and recommendations for senior leaders and tailor communication content and style for stakeholder understanding
- Experience providing strategic feedback to vendors and synthesizing multiple analyses to solve broader business issues
- Ability to represent the discipline or function on program/project teams
- Ability to identify capability gaps, ensure developmental opportunities for colleagues, set direction with little guidance, contribute to multiple topic areas, and drive functional direction
- Must be willing to wear personal protective equipment (PPE) as required
- Must be comfortable working around radioactive materials
Benefits
Comp & perks- Additional discretionary incentive cash and stock opportunities
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
- 3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
- Paid sick leave, depending on eligibility
- Up to two paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- Annual Global Shutdown between Christmas Day and New Year's Day
- Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities