Director, Engineering

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.  \

Job Title: Director, AI Engineering

 

Location: USA Remote

 

Function: AI Development 

 

We are seeking a strategic and technically exceptional Director of AI Engineering to lead the design, development, and deployment of AI-driven solutions across our clinical research, eClinical, and eCompliance platforms. As a key member of our technology leadership team, you will drive innovation in applying artificial intelligence and machine learning to improve trial efficiency, regulatory compliance, and clinical data integrity within a GxP-regulated environment. 

This role is ideal for a collaborative leader with deep expertise in AI/ML, strong engineering management skills, and a passion for transforming the clinical research ecosystem through responsible, secure, and scalable technology.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Develop and own the AI/ML roadmap aligned with company goals. 

• Lead the strategic direction for AI initiatives supporting decentralized trials, eSource data, eCOA, EDC, and regulatory systems. 

• Identify opportunities for automation, prediction, and decision support within clinical trial workflows and quality systems. 

• Build, mentor, and lead a high-performing team of AI/ML engineers, data scientists, and software developers. 

• Define and enforce best practices in AI model development, MLOps, and software engineering. 

• Collaborate with cross-functional leaders to deliver reliable, interpretable, and compliant solutions. 

• Oversee the end-to-end development lifecycle of AI-powered features within our eClinical and eCompliance platforms. 

• Partner with Product and UX teams to ensure AI tools are intuitive, actionable, and add measurable value to trial sponsors and sites. 

• Ensure timely delivery and deployment of scalable AI components within cloud-native Azure environments. 

• Develop AI governance frameworks and ensure alignment with industry regulations (ICH E6(R3), 21 CFR Part 11, GDPR, HIPAA). 

• Drive responsible AI practices with explainable, auditable, and bias-mitigated models. 

• Collaborate with Quality Assurance and Compliance teams to validate AI systems used in clinical and regulatory contexts. 

• Stay up-to-date with the latest developments in natural language processing (NLP), computer vision, and generative AI relevant to the life sciences domain. 

• Foster partnerships with external research institutions, technology vendors, and regulatory bodies to inform and validate AI innovations. 

EDUCATION AND EXPERIENCE REQUIRED: 

• Master’s or Ph.D. in Computer Science, Engineering, Data Science, or a related field. 

• 10+ years of experience in software engineering and/or data science, with at least 5 years in AI/ML leadership roles.