Lead AI Engineer Biomedical Vigilance Innovation

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The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

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 casesDevelop tools that support adverse event intake, case triage, coding assistance, duplicate detection, signal prioritization, and trend analysisEngineer predictive models to identify emerging risks, patient patterns, and operational bottlenecksTranslate complex scientific and business requirements into production-ready AI applicationsDeep 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 casesDefine 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 OrganizationDrive the architecture, development, and delivery of next-generation platforms for pharmacovigilance technological AI initiativesIntegrate structured and unstructured datasets from safety databases, clinical systems, literature sources, real-world evidence, and external repositoriesHand-on experience of creating staging schemas and data mining varied sources to uncover hidden trends & patterns turning into meaningful insightsBuild scalable pipelines for ingestion, transformation, and quality control of biomedical dataApply ontology mapping, terminology harmonization, and metadata strategies across MedDRA, WHO Drug, and related standardsEnsure robust data lineage, traceability, and audit readinessSupport modernization of pharmacovigilance and Organovigilance systems through AI enabled automation and decision support toolsImprove case processing efficiency, medical review, and governance reporting through AI-enabled solutionsContribute to next-generation surveillance models for novel modalities including xenotransplantation, cell therapy, gene therapy, and organ-based therapeuticsDevelop AI enabled dashboards and visualization tools that enable rapid interpretation of safety trendsEnsure AI models and digital tools are developed in alignment with GxP, privacy, security, validation, and regulatory expectationsSupport model governance frameworks including performance monitoring, unbiased detection, explainability (XAI), and change controlMaintain documentation for validation, testing, intended use, and lifecycle managementCollaborate with other Safety Functions, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, and IT functionsProvide technical guidance to analysts, data scientists, and business partnersDeliver validated AI solutions that create measurable gains in vigilance quality, speed, and insight generationImprove detection and prioritization of safety signals through advanced analyticsEnhance case processing and review efficiency while preserving quality and complianceEstablish reliable, scalable biomedical data assets for future innovationMaintain regulatory-ready governance for AI-enabled safety systemsAdvance UTC’s leadership position in responsible AI for the future of medicinePerform 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 orMaster’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 orDoctor 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 experience5+ years of experience in AI engineering, machine learning, or advanced analytics within biopharma, healthcare, or regulated industries and5+ 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 environmentsEntrepreneurial, transformation-oriented mindset with the ability to move from concept to execution quickly, sustain momentum through ambiguity, and lead organizations through technology-driven changeBackground 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 themFamiliarity with data architecture, cloud computing, and innovative analytics platformsStrong problem-solving capability with the ability to operate in complex matrixed environmentsDeep fluency in cloud-native engineering, platform architecture, and modern software development practicesExperience with external innovation strategies, academic partnerships, and emerging technology investments that extend organizational capability beyond organic developmentHave the engineering mindset to build platforms that are production-grade, compliant, and scalable not just proof-of-concept demonstrationsCommunicate technical outputs clearly to non-technical stakeholders and senior leadershipLearn 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 miningExperience with safety systems such as Argus, ArisG, Veeva, or equivalent platformsKnowledge of pharmacovigilance, clinical development, biomedical data, or healthcare regulations preferredExposure to drugs, biologics, devices in rare disease space, or advanced therapeuticsCuriosity about and willingness to develop deep understanding of pharmaceutical domain and automation workflows, advance analytics or benefit risk identification methodologies implementationHands-on experience with Pharmacokinetic(PK)/ Pharmacodynamics (PD) modeling and simulation & its applications to AI in PharmacovigilanceFamiliarity with GVP, FDA, EMA, ICH, and data privacy frameworksBring the startup urgency to cut through complexity and ship results, while maintaining the regulatory discipline that the PV industry demandsSee 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.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.