Teams at Eli Lilly and Company

Lead population PK and PK/PD modeling across drug development programs using NONMEM or Monolix and R. Own analysis plans, regulatory-standard reports, simulations, quality review, and scientific responses on dose, regimen, and patient population. Partner cross-functionally with statistics, regulatory, medical, ADME, toxicology, and clinical development teams. Contribute to automation, AI/ML integration, reproducible workflows, and scientific communication with project teams, leadership, regulators, and external audiences.

Provides technical leadership for downstream process development and scale-up of genetic medicines. Supports tech transfer from small-scale purification to manufacturing scale, analyzes yields, chromatograms, filtration performance, and process variability, and troubleshoots unit operations. Develops technical agendas, collaborates with development teams, maintains records, interprets data, and creates SOPs, protocols, specifications, and work instructions. Requires expertise in filtration, chromatography, ultracentrifugation, and TFF.

Lead ADME and DMPK activities supporting preclinical and clinical development of genetic medicines, including gene therapies, gene editing, siRNAs, and ASOs. Design and interpret ADME, PK/PD, and toxicokinetic studies; integrate multidisciplinary data to guide drug design and delivery; prepare regulatory documentation; interact with regulatory authorities; and mentor colleagues. The role requires a Ph.D. in a related scientific field and more than five years of pharmaceutical or biotechnology ADME or PK/PD experience.