Principal Software Engineer

Sitero LLC•Markham, ON

18d•Hybrid

About The Position

Sitero is a next-generation clinical trial solutions partner, supporting more than 200 Pharmaceutical, Biotech, and Institutional Research Organizations globally. We leverage advanced technology, data, and AI to drive safety, compliance, quality, and operational efficiency—enabling our customers to bring life-changing therapies to market faster and more reliably. Our innovation is rooted in a clear mission: to advance clinical research through an AI-first, technology-enabled delivery model. As we scale, AI is no longer a feature—it is foundational to how we build, operate, and deliver across the enterprise. At Sitero, you will operate at the forefront of AI-driven transformation in clinical research. This role offers the opportunity to architect systems that directly impact human health while shaping how AI is embedded across products, workflows, and engineering practices. You will join a high-growth, innovation-focused environment where you can influence enterprise-wide strategy, work across disciplines, and help define what “AI-native” looks like in a regulated industry. We are seeking a Principal Software Engineer to define and lead the next generation of AI-powered Clinical Trial Management Systems. This is a highly strategic, hands-on leadership role responsible for architecting scalable, AI-native systems across our technology ecosystem. You will operate at the intersection of software architecture, machine learning infrastructure, and applied AI, driving both product innovation and internal engineering transformation. You will act as a technical authority and multiplier, shaping how AI is embedded into our platforms, how our teams build software, and how we scale intelligent systems across a global organization.

Requirements

Bachelor’s degree in Computer Science, Engineering, or related field (or equivalent practical experience)
10+ years of experience in software engineering, with deep expertise in distributed systems and full-stack architecture
5+ years in senior technical leadership roles, driving architecture and influencing cross-functional teams
7+ years designing and scaling machine learning systems and infrastructure in production environments
Proven experience with modern AI techniques, including LLMs, multi-modal models, and agent-based systems
Deep hands-on experience integrating AI into real-world applications and production systems
Demonstrated expertise in AI-augmented development workflows and engineering productivity tooling
Experience working with large-scale data systems, high-performance computing, or cloud-native architectures

Nice To Haves

Master’s or PhD in Computer Science, Engineering, AI, or related field
Experience building AI systems in regulated environments (e.g., healthcare, life sciences, finance)
Deep fluency in SQL and data engineering best practices
Proven ability to lead enterprise-wide AI transformation initiatives
Experience operating in complex, global, cross-functional organizations

Responsibilities

Investigate, identify, and triage architectural improvements to modernize a core top 10 pharma product to be AI-enabled
Build, manage, and lead a team of developers to ship an industry leading CTMS product
Work cross-functionally with service delivery and commercial teams to help navigate and understand and translate technical designs to customer value
Work directly with product management to deliver customer-delighting features
Define and drive the enterprise AI architecture roadmap, aligning AI capabilities with product and business strategy
Architect AI-native systems that integrate LLMs, multi-modal models, and intelligent agents into core clinical platforms
Establish scalable patterns for model deployment, orchestration, evaluation, and governance in regulated environments
Champion and institutionalize AI-augmented software development practices across engineering teams
Drive adoption of LLM-powered workflows for code generation, testing, refactoring, documentation, and system design
Establish best practices for human-in-the-loop AI development and engineering productivity acceleration
Partner with Product, Clinical, and QA teams to embed AI-driven capabilities into Sitero’s platforms (e.g., automation, decision support, predictive insights)
Design and implement agentic systems that enhance workflows across clinical operations, safety, regulatory, and data management
Serve as a senior technical leader and advisor across the organization, influencing architecture decisions and long-term strategy
Mentor and elevate engineering talent, setting a high bar for technical excellence and AI fluency
Drive alignment across cross-functional teams in a globally distributed environment
Ensure AI systems meet GxP, regulatory, and data governance standards required in clinical research
Balance innovation with robustness, explainability, and auditability
Continuously optimize system performance, cost efficiency, and scalability