Adme Project Leadership for Genetic Medicines

Eli Lilly Eli Lilly · Pharma · Boston, MA

This role focuses on ADME (Absorption, Distribution, Metabolism, and Excretion) and DMPK (Drug Metabolism and Pharmacokinetics) studies for genetic medicines, including siRNAs, ASOs, mRNAs, gene editing, and gene therapy. The scientist will lead studies, interpret data, and collaborate with multidisciplinary teams to support preclinical and clinical development, and prepare regulatory communications. The role requires a PhD and experience in pharmaceutical/biotechnology settings, with knowledge of PK/PD modeling and bioanalytical methods being preferred.

What you'd actually do

  1. 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
  2. Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
  3. Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies.
  4. Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
  5. 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

Skills

Required

  • Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
  • Zero to five years of experience as a scientist in a pharmaceutical and/or biotechnology company
  • High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules
  • 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
  • Excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams

Nice to have

  • 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

What the JD emphasized

  • 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