Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Assoc. Director, IT Regulatory, Clinical and Enterprise Systems Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

Rayze Bio, 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. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals.

The Assoc. Director, IT Regulatory, Clinical and Enterprise Systems is an integral part of bringing Rayze Bio’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 Rayze Bio’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.

• 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.

#Rayze Bio, #LI-Onsite

• 10+ years’ IT experience in a cGMP injectable or Radiopharmaceutical environment.
• Proven technical leadership and management experience.
• Demonstrated experience…