Associate Director, IT Regulatory, Clinical, and Enterprise Systems at Bristol-Myers Squibb

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, OncologyIndustries

Requirements

Experience with operational solutions for regulatory and clinical operations, large corporate systems, and small biotech systems
Ability to work across all assigned functions including Clinical Operations, Regulatory, Planning, and Enterprise Systems
Capability to set and manage budgets
Experience working with architectural and IT partners, as well as business partners

Responsibilities

Accountable for continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply chain planning, and related Enterprise Systems (e.g., clinical site portal, RIM, supply chain planning, and other regulated functional solutions, including associated infrastructure)
Deliver on service level management scope and process with IT groups and/or vendor managed services (e.g., Service Level Agreements (SLAs), Disaster Recovery/Service Continuity)
Ensure Digital Roadmap is 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
Act as an active partner with 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 is delivered for the functions
Manage new demand and evolve digital solutions and mindset
Identify key technology trends and how innovative technologies apply

Skills

IT Regulatory Systems

Clinical Systems

Enterprise Systems

GXP Compliance

Validation

Biotechnology IT

Radiopharmaceuticals

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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