Director, IT R&D and Quality Applications

Responsibilities

• Serve as the lead IT partner across Clinical Operations, Data Management, Biometrics.
• Oversee systems supporting regulatory submissions, pharmacovigilance, and quality management.
• Support complex clinical trials involving decentralized models, subject diaries, and connected devices.
• Lead implementation and support of R&D systems including Clinical Trial management solutions such as CTMS, EDC, eTMF, ePRO/eCOA, IRT, and consolidated clinical analytics solutions.
• Spearhead use & enablement of AI solutions within R&D, Clinical & Quality systems.
• Develop integration strategy across clinical data ecosystems including the Veeva Vault R&D Suite and analytics environments.
• Ensure compliance with GxP regulations including ICH E6(R3), 21 CFR Part 11, and data integrity (ALCOA+).
• Lead technology solutioning including vendor selection, RFP processes, and vendor relationship management.
• Manage system roadmap, budgeting, and portfolio prioritization.

Requirements

• Bachelor’s degree in computer science, Life Sciences, or related field.
• 10+ years of Life sciences business applications experience with 5+ years implementing and supporting R&D / Clinical Systems.
• Experience with clinical trial systems is required (CTMS, eTMF, eCRO, ePRO).
• Experience with clinical data management (EDC, CDB) and Biometric analytical platforms preferred.
• Deep expertise in Veeva Vault R&D Suite (Clinical, RIM, Quality, Safety).
• Expertise in integrating complex clinical data sources including ePRO, wearables, and medical devices.
• Strong knowledge of GxP regulations, CDISC standards (SDTM, ADaM) and Computer System Assurance frameworks.
• Experience managing cross-functional teams and SaaS-based vendors.
• Excellent communication and problem-solving skills.