Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Bristol-Myers Squibb; San Diego (CA); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

RayzeBio, a Bristol Myers Squibb company, is advancing radiopharmaceuticals to improve cancer outcomes. The Associate Director IT Regulatory, Clinical and Enterprise Systems will lead digital infrastructure across Regulatory, Clinical Operations and Planning, reporting to the Exec. Director IT.

Based in San Diego or Indianapolis, the role focuses on compliant, scalable IT solutions, budgeting, and partnerships with architects and business teams to enable commercialization goals.

Competenze

• 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.

Mansioni

• Accountable for continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply chain planning and related Enterprise Systems.
• Deliver on service level management scope and process with IT groups and/or vendor managed services, i.e., Service Level Agreements (SLA's).
• 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.
• Active partner with the functional leaders 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.

Conoscenze

Project management

Stakeholder influence

Leadership

Multi-disciplinary projects

Communication

Strategic thinking

Formazione

BS/MS Information Technology

Equivalent experience

Descrizione del lavoro

Life at BMS

At 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.