ADME Project Leadership for Genetic Medicines

Job Summary

Lilly is seeking a skilled ADME / DMPK scientist to lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio.

Responsibilities

• Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio
• Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
• Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies
• Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
• Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities
• Mentor and support junior scientists and build relationships through coaching and mentorship with fellow scientists at all levels

Qualifications

• Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
• Greater than five years of experience as a scientist in a pharmaceutical and/or biotechnology company in a role related to ADME or PK/PD
• Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities
• Understanding of pharmaceutical regulatory guidance and expectations
• Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics

Additional Skills/Preferences

• Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics
• Experience with PK/PD modeling and simulation
• Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies
• Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology