Associate Director, IT Regulatory, Clinical, and Enterprise Systems

Bristol Myers Squibb•Indianapolis, IN

46d•$166,139 - $221,454•Onsite

About The Position

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

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.
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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