Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Bristol-Myers Squibb Company; New Jersey; Presencial; USD 166.000 - 221.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

Flexible time off and holidays

Vacation benefits

Company-wide shutdown

Resumo da vaga

RayzeBio, a Bristol Myers Squibb company, seeks an Associate Director of IT Regulatory, Clinical and Enterprise Systems to lead digital solutions across Clinical Operations, Regulatory, Planning and Enterprise Systems. You will partner cross-functionally to enable growth, manage budgets, and drive a modern IT roadmap for radiopharmaceutical technologies.

Based in the US with on-site locations in Indianapolis or San Diego, you will guide regulatory inspection readiness, data integrity

Qualificações

• 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

Responsabilidades

• Ensure Digital Roadmap is leveraged and aligned to business outcomes.
• Lead a group of indirect reports and service providers.
• Provide IT leadership to regulatory inspection readiness and data integrity initiatives.
• Manage new demand and evolve digital solutions and mindset.
• Identify key technology trends and how innovative technologies might be leveraged.
• Participate in high-level strategic communications with business and leadership teams.
• Develop long-term roadmaps (3 years) for capabilities with greatest impact.
• Apply AI to improve team execution and decision-making.

Conhecimentos

Project leadership

Regulatory IT

Automation

Stakeholder influence

Budget management

Formação

BS/MS Information Technology or similar

Ferramentas

RIM

ERP systems

Descrição da vaga

Life at BMSAt RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Learn more about RayzeBio: https://careers.bms.com/rayzebio/

Position

Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Location: Indianapolis, IN or San Diego, CA

Background

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Description

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. The role will ensure that the digital systems roadmap is enabled and maintained to successfully deliver novel Radiopharmaceutical technologies. You will work with operational solutions for regulatory and clinical operations, large corporate systems, small biotech systems, across all assigned functions. Additional responsibilities will include setting and managing budgets and working with architectural and IT partners and business partners to achieve our technology and commercialization goals.

Job Responsibilities

• Accountable for continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply chain planning and related Enterprise Systems. These systems include clinical site portal, RIM, supply chain planning, and other regulated functional solutions. Scope will also include associated infrastructure.
• Deliver on service level management scope and process with IT groups and/or vendor managed services, i.e., Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
• 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 that meet the needs of the organization.
• Active partner with the functional leaders. 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 to the organization.
• Participate in high-level strategic communications with the business and functional leadership teams
• Responsible for the development of long-term (3 year) roadmaps identifying capabilities that have the greatest impact on business capabilities for the organization. Partnering and benchmarking 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.
• It requires strong influence and trust, resilience in demanding situations, and the ability to encourage calm and rational behavior in teams.
• The leader identifies multiple solutions and recommendations for senior leaders, structures communications to achieve organizational goals, and tailors communication content and style for stakeholder understanding.
• The role also involves providing strategic feedback to vendors, synthesizing multiple analyses to solve broader business issues, and representing the discipline or function on program/project teams.
• Additionally, the leader identifies gaps in capabilities, ensures developmental opportunities for colleagues, sets direction with little guidance, contributes to multiple topic areas, and 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

Compensation Overview

Indianapolis - RayzeBio - IN: $166,139 - $201,322

San Diego - CA - US: $182,753 - $221,454

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608246 : Associate Director, IT Regulatory, Clinical, and Enterprise Systems