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. 

• Proven experience delivering AI solutions within highly regulated industries (life sciences, healthcare, financial services, etc.). 

• Strong technical proficiency in Python, ML frameworks (TensorFlow, PyTorch, Scikit-learn), and MLOps tools (MLflow, Kubeflow, SageMaker, etc.). 

• Deep understanding of Azure cloud infrastructure and microservices architectures. 

• Experience working with clinical trial systems such as EDC, ePRO, CTMS, and eTMF is strongly preferred. 

Preferred Qualifications 

• Familiarity with validation processes for AI/ML software in regulated environments. 

• Understanding of regulatory AI guidelines (e.g., FDA’s AI/ML Action Plan, EMA AI Reflection Paper). 

• Experience applying AI to unstructured data from clinical notes, adverse event reports, or scanned documents. 

• Experience integrating AI into enterprise SaaS platforms or LIMS/eQMS tools. 

COMPENSATION & BENEFITS: 

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.  

EMPLOYMENT TYPE: 

Full Time, Permanent 

COMMITMENTS: 

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday.  
  Additional hours as needed.  

• Willing to work in shifts as and when needed. 

DISCLAIMER:  

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. 

Salary : $185