Associate Director, IT – Development, Research, CMC Business Partner

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.
• Demonstrated experience supporting Clinical Development, Research, and/or CMC functions.
• Strong hands-on experience with SAS environments supporting clinical data analysis.
• Deep understanding of GxP regulations, system validation, data integrity principles, and 21 CFR Part 11.
• Experience supporting clinical, quality, manufacturing, and analytics platforms in regulated environments.

Tech Stack

• Google Cloud Platform

Benefits

• annual bonus
• stock-based long-term incentives
• medical, dental, and vision benefits
• retirement
• wellness stipend
• flexible time off