Lead AI Engineer, Biomedical & Vigilance Innovation

Role: Lead AI Engineer in Biomedical & Vigilance Innovation focusing on developing advanced AI solutions for pharmacovigilance, biomedical research, and safety signal detection. Responsibilities: design, validate, and deploy machine learning, NLP, and generative AI tools to support adverse event intake, case triage, risk assessment, and trend analysis; develop predictive models for emerging risks; create scalable platforms integrating diverse biomedical datasets; ensure compliance with GxP, privacy, and regulatory standards; collaborate across safety, clinical, regulatory, and IT functions; and contribute to next-generation vigilance systems for modalities including cell, gene, and organ-based therapeutics. Requirements: Bachelor's (8+ years), Master's (6+ years), or PhD (2+ years) in computer science, biomedical engineering, or related fields; 5+ years in AI engineering within biopharma or healthcare; hands-on experience with AI tools (Python/R, TensorFlow/PyTorch, cloud platforms); proven track record of solutions delivering measurable outcomes in regulated environments; strong problem-solving and cross-functional communication skills. Preferred: expertise in NLP, LLMs, knowledge graphs, pharmacovigilance systems (Argus, Veeva), experience with biomedical data, safety system familiarity, and knowledge of regulatory frameworks (FDA, EMA, ICH). High-value specifics include focus on pharmacovigilance, rare disease therapeutics, and AI-driven safety and research platforms. Work setup: hybrid Durham, NC with 4 days onsite and 1 day remote.