Senior Software Engineer II, Trial Engine

Role: Senior Software Engineer II focusing on developing and operating regulated clinical trial software within a GxP environment. Primary objectives include building integrated systems for trial activation, data collection, monitoring, and signal detection, with a strong emphasis on AI-native capabilities and compliance. Responsibilities encompass designing validated, auditable software integrated with clinical systems (EDC, CTMS, labs), collaborating across clinical, regulatory, and data teams, and translating GxP requirements into scalable solutions. The role involves technical ownership of key trial functions, guiding cross-quarter projects from concept to deployment, and ensuring regulatory adherence through partnership with QA and validation experts. Qualifications: 7+ years in production software development, hands-on experience with clinical data flows, and familiarity with regulated environments (GxP/GCP, validation, audit trails). Technical skills in distributed systems, cloud platforms (AWS, GCP, Azure), and AI tools are essential. Strong communication skills for cross-functional engagement and experience with multi-quarter projects are required. High-Value Biopharma Details: Focus on clinical trials in regulated settings, with an emphasis on integrating AI and automation to accelerate drug development. The position supports active trials in diverse therapeutic areas, leveraging modern data platforms and ensuring compliance throughout the software lifecycle. Location: Hybrid in New York City or Boston; consideration for Research Triangle or Bay Area candidates.