Associate Director, IT Regulatory, Clinical, and Enterprise Systems
Bristol Myers Squibb
Summary
The Assoc. Director, IT Regulatory, Clinical and Enterprise Systems is an integral part of bringing RayzeBio's innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be primarily responsible for implementing RayzeBio's vision for growth and leading efforts to enable digital processes to achieve commercialization objectives across the Clinical Operations, Regulatory, Planning and Enterprise Systems.
Job description
Job 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, plus associated infrastructure.
- Deliver on service level management scope and process with IT groups and/or vendor managed services (SLAs, Disaster Recovery/Service Continuity).
- Ensure Digital Roadmap leveraged and aligned to business outcomes; drive for value realization.
- Lead a group of indirect reports and service providers to deliver effective, innovative and stable solutions.
- Partner with functional leaders and collaborate with leadership to develop, support, 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 delivered for the functions.
- Manage new demand and evolve digital solutions and mindset.
- Identify key technology trends and how innovative technologies might be leveraged to provide solutions.
- Participate in high-level strategic communications with business and functional leadership teams.
- Develop long-term (3 year) roadmaps identifying capabilities with the greatest impact on business capabilities; partner and benchmark with external sources.
- Applies AI to improve team execution and decision-making.
Education and Experience
- 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.
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.
- Strong influence and trust, resilience in demanding situations, ability to encourage calm and rational behavior in teams.
- Identifies multiple solutions and recommendations for senior leaders, structures communications to achieve organizational goals, tailors communication content and style for stakeholder understanding.
- Provides strategic feedback to vendors, synthesizes multiple analyses to solve broader business issues, represents the discipline or function on program/project teams.
- Identifies gaps in capabilities, ensures developmental opportunities for colleagues, sets direction with little guidance, contributes to multiple topic areas, drives functional direction.
Physical Requirements
- Standard office environment coupled with GMP production and facility environment.
- Must be willing to wear personal protective equipment (PPE) as required.
- Must be comfortable working around radioactive materials.
- Periodic travel to other RayzeBio locations.
Requirements
- 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
- Leads complex, multi-disciplinary projects including resource and budget allocation and operational leadership
- Must be willing to wear personal protective equipment (PPE) as required
- Must be comfortable working around radioactive materials
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Retirement Benefits
- Flexible Time Off
- Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.