Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Bristol Myers Squibb • Indianapolis, IN

11d • $166,139 - $221,454 • Onsite

About The Position

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: careers.bms.com/working-with-us . 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. 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.

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.
• 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.

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees