Senior Principal Software and AI Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, develop, and implement AI and agentic applications for protocol generation and execution of clinical trials.

• Streamline workflows from study design to operational execution.

• Collaborate with clinicians, medical writers, statisticians, data scientists, clinical operations, and product teams.

• Create a scalable and dependable architecture for multi-agent orchestration, integration of models and tools, and the complete LLMOps lifecycle.

• Establish optimal practices for AI-centric development, assessment, testing, observability, and ongoing performance monitoring within a validated SDLC.

• Evaluate frontier and open-weight models, agent frameworks, and tools.

• Make decisions regarding building, purchasing, and sourcing models.

• Maintain GxP, data privacy, security, and responsible AI standards.

• Incorporate traceability, auditability, and human oversight into systems.

• Lead product development and technical strategy from initial concept to production.

• Oversee project execution, priorities, scope, and timelines for the AI engineering team.

• Guide AI and software engineers through design and code reviews, reference implementations, and practical support.

• Direct cross-functional technical initiatives with partners in clinical, medical writing, biostatistics, and clinical operations.

⛳️ Requirements

• Bachelor's degree with 7+ years of experience, Master's degree with 5+ years of experience, or PhD with 3+ years of experience.

• Background in software and AI/ML engineering.

• Experience serving as a tech lead or principal engineer responsible for large-scale AI products from start to finish.

• Proven track record in delivering production-grade AI and agentic applications.

• Strong foundation in software engineering.

• In-depth backend knowledge in Python and/or .NET.

• Experience in architecting enterprise applications that encompass frontend, APIs, databases, and deployment.

• Practical experience with PostgreSQL, Elasticsearch, and Neo4j or similar relational, search, and graph data storage solutions.

• Background in architecting and deploying multi-agent applications in a production environment.

• Familiarity with agent harness design, context engineering, orchestration, tool integration (including MCP), and human-in-the-loop controls.

• Experience in selecting and utilizing frontier and open-weight models.

• Knowledge of structured outputs, guardrails, and model validation.

• Experience with fine-tuning or post-training is an advantage.

• Capability to design and manage enterprise knowledge architecture, ontology design, knowledge graphs, and retrieval systems.

• Skill in creating multi-layered evaluations and production monitoring systems.

• Proficiency with AI coding tools and methodologies.

• Strong experience in rigorous testing, code review, and CI/CD practices.

• Comprehensive knowledge of LLMOps, secure cloud deployment using AWS, Azure, or GCP, and observability practices.

• Experience in clinical protocol development, study design, or clinical trial operations.

• Familiarity with ICH M11 structured protocols, CDISC standards, or USDM is highly desirable.

• Understanding of GxP, computer system validation, and emerging regulatory guidelines regarding AI in drug development.

• Demonstrated ability to serve as a tech lead, guide product direction and delivery, and mentor senior engineers.

• Ability to collaborate effectively with clinicians, medical writers, statisticians, and clinical operations teams.

• Commitment to data privacy, security, and responsible AI practices.

• Willingness to travel up to 10% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life Insurance coverage.

• Paid Time Off.

• Wellness programs.