Lead AI Engineer, Biomedical & Vigilance Innovation

California, US residents .

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 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 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.

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