Principal Software Engineer

Job Title: Principal Software Engineer

Location: Miami, Florida or Ontario, Canada
Function: AI Engineering for Clinical Trial Management Systems

About Sitero

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.

Why Sitero?

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.

About the Role

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.

Key Responsibilities

Product modernization

• 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

AI Strategy & Architecture Leadership

• 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

AI-Native Engineering Transformation

• 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

Product Innovation & Intelligent Systems

• 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

Technical Leadership & Influence

• 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

Performance, Compliance & Scalability

• 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

Minimum Qualifications

• 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

Preferred Qualifications

• 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

What Success Looks Like

• AI is embedded as a core capability across Sitero’s platforms, not a bolt-on feature
• Engineering teams operate with AI-native workflows, significantly increasing speed and quality
• Scalable, compliant AI systems are deployed across clinical domains, driving measurable impact