Associate Director, IT – Development, Research, CMC Business Partner
United States
Full Time
8 hours ago
$171,000 - $199,500 USD
H1B Sponsor
Key skills
Google Cloud PlatformAnalyticsGCPGoogle CloudChange Management
About this role
Role Overview
Act as the primary business systems partner for Clinical Development, Research, and CMC teams, translating scientific, operational, and analytical needs into compliant, scalable system solutions.
Provide strategic oversight of systems supporting clinical trials, research operations, manufacturing, quality, and clinical data analysis, ensuring data integrity, traceability, and inspection readiness.
Partner with Clinical Operations, Biostatistics, Data Management, Research, Technical Operations, and Quality to define system roadmaps aligned with development milestones.
Lead oversight and governance of SAS environments used for clinical data analysis.
Partner with Biostatistics, Clinical Data Management, and external vendors to support the use of SAS for analysis and reporting.
Own the lifecycle management of regulated and enterprise systems, including selection, implementation, validation, integration, and ongoing optimization.
Ensure effective system integrations and data flows between clinical, analytical, quality, and CMC systems.
Serve as a subject matter expert on system controls, access management, and change management in regulated environments.
Lead GxP compliance for systems supporting GCP, GMP, and GLP activities as applicable.
Partner closely with Quality to support regulatory inspections, audits, and system-related responses.
Develop, maintain, and enforce policies, SOPs, and controls governing validated systems, data integrity, and compliance.
Serve as a trusted liaison between Clinical Development, Biostatistics, Data Management, Research, CMC, Quality, IT, and external vendors.
Provide guidance, training, and best practices to stakeholders on compliant system use.
Influence adoption of standardized, compliant solutions across Development and CMC teams.
Proactively identify system gaps, compliance risks, and opportunities to improve efficiency across Development, analytics, and CMC operations.
Requirements
8+ years of experience in business systems, regulated systems, or IT compliance within biotech, pharmaceutical, or life sciences organizations.