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The job details are as follows:

We are seeking a Lead AI Engineer, Biomedical & Vigilance Innovation with a start-up mindset to drive the design, development, and deployment of advanced AI solutions that transform how biomedical insights are generated and how safety signals are detected, assessed, and acted upon, as well as deploying artificial intelligence solutions that strengthen biomedical research, patient safety, and next-generation vigilance capabilities.

This role operates at the intersection of data science, software engineering, and medical safety, applying advanced analytics, machine learning, and automation signal detection, case intelligence, business efficiency, and evidence generation from various sources of scientific and RWD. The position will partner closely with safety physicians, clinical scientists, epidemiologists, regulatory leaders, and technology teams to create scalable platforms that support proactive risk management and accelerate informed decision-making across the product lifecycle. This role is instrumental in shaping the future state of digital vigilance and precision medicine.

• Design, build, validate, and maintain machine learning, natural language processing, and generative AI solutions for biomedical and pharmacovigilance use cases
• Develop tools that support adverse event intake, case triage, coding assistance, duplicate detection, signal prioritization, and trend analysis
• Engineer predictive models to identify emerging risks, patient patterns, and operational bottlenecks
• Translate complex scientific and business requirements into production-ready AI applications
• Deep understanding & Hands-on experience of know-how of model definitions and fine-tuning models to make them efficient and fit for purpose to UT PV business use cases
• Define and execute a bold technology strategy spanning the Global Patient Safety covering usage of AI in day-to-day PV operations, analytical sciences, signal detection, process scale up with a clear mandate to embed AI, machine learning, and agentic automation throughout, within the UT Global Patient Safety Organization
• Drive the architecture, development, and delivery of next-generation platforms for pharmacovigilance technological AI initiatives
• Integrate structured and unstructured datasets from safety databases, clinical systems, literature sources, real-world evidence, and external repositories
• Hand-on experience of creating staging schemas and data mining varied sources to uncover hidden trends & patterns turning into meaningful insights
• Build scalable pipelines for ingestion, transformation, and quality control of biomedical data
• Apply ontology mapping, terminology harmonization, and metadata strategies across MedDRA, WHO Drug, and related standards
• Ensure robust data lineage, traceability, and audit readiness
• Support modernization of pharmacovigilance and Organovigilance systems through AI enabled automation and decision support tools
• Improve case processing efficiency, medical review, and governance reporting through AI-enabled solutions
• Contribute to next-generation surveillance models for novel modalities including xenotransplantation, cell therapy, gene therapy, and organ-based therapeutics
• Develop AI enabled dashboards and visualization tools that enable rapid interpretation of safety trends
• Ensure AI models and digital tools are developed in alignment with GxP, privacy, security, validation, and regulatory expectations
• Support model governance frameworks including performance monitoring, unbiased detection, explainability (XAI), and change control
• Maintain documentation for validation, testing, intended use, and lifecycle management
• Collaborate with other Safety Functions, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, and IT functions
• Provide technical guidance to analysts, data scientists, and business partners
• Deliver validated AI solutions that create measurable gains in vigilance quality, speed, and insight generation
• Improve detection and prioritization of safety signals through advanced analytics
• Enhance case processing and review efficiency while preserving quality and compliance
• Establish reliable, scalable biomedical data assets for future innovation
• Maintain regulatory-ready governance for AI-enabled safety systems
• Advance UTC's leadership position in responsible AI for the future of medicine
• Perform other duties as required

Minimum Requirements

• Bachelor's Degree in computer science, science, engineering, applied mathematics, data science, biomedical engineering, bioinformatics, artificial intelligence, or related discipline with 8+ years of relevant experience or
• Master's Degree in computer science, science, engineering, applied mathematics, data science, biomedical engineering, bioinformatics, artificial intelligence, or related discipline with 6+ years of relevant experience or
• Doctor of Philosophy (PhD) in computer science, science, engineering, applied mathematics, data science, biomedical engineering, bioinformatics, artificial intelligence, or related discipline with 2+ years of relevant experience
• 5+ years of experience in AI engineering, machine learning, or advanced analytics within biopharma, healthcare, or regulated industries and
• 5+ years of hands-on expertise in AI tools ( e.g. Python/R/Matlab for ML, TensorFlow/PyTorch, cloud-based ML platforms )
• Track record of applying AI, machine learning, and data science to solve hard problems in complex domains not just strategy but working implementations that have delivered measurable outcomes in production environments
• Entrepreneurial, transformation-oriented mindset with the ability to move from concept to execution quickly, sustain momentum through ambiguity, and lead organizations through technology-driven change
• Background in AI-native product development including agentic AI, LLM-powered applications, autonomous systems, computer vision, or ML-driven process optimization with hands-on experience developing & implementing AI products, not just evaluating them
• Familiarity with data architecture, cloud computing, and innovative analytics platforms
• Strong problem-solving capability with the ability to operate in complex matrixed environments
• Deep fluency in cloud-native engineering, platform architecture, and modern software development practices
• Experience with external innovation strategies, academic partnerships, and emerging technology investments that extend organizational capability beyond organic development
• Have the engineering mindset to build platforms that are production-grade, compliant, and scalable not just proof-of-concept demonstrations
• Communicate technical outputs clearly to non-technical stakeholders and senior leadership
• Learn the science quickly and develop enough depth to challenge assumptions, ask the right questions, and identify where technology can create step-change improvements in manufacturing timelines, quality, and cost

Preferred Qualifications

• 5+ years of experience with NLP, LLMs, knowledge graphs, or biomedical text mining
• Experience with safety systems such as Argus, ArisG, Veeva, or equivalent platforms
• Knowledge of pharmacovigilance, clinical development, biomedical data, or healthcare regulations preferred
• Exposure to drugs, biologics, devices in rare disease space, or advanced therapeutics
• Curiosity about and willingness to develop deep understanding of pharmaceutical domain and automation workflows, advance analytics or benefit risk identification methodologies implementation
• Hands-on experience with Pharmacokinetic(PK)/ Pharmacodynamics (PD) modeling and simulation & its applications to AI in Pharmacovigilance
• Familiarity with GVP, FDA, EMA, ICH, and data privacy frameworks
• Bring the startup urgency to cut through complexity and ship results, while maintaining the regulatory discipline that the PV industry demands
• See AI as a practical toolkit knowing when and how to apply machine learning, NLP, computer vision, or agentic systems to specific manufacturing and PV workflows to deliver real operational advantages

Job Location

This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities