Director/ Senior Director/ Executive Director – Translational Pkpd Project Leader

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN +1

This role focuses on leading PKPD project strategy for genetic medicines programs, developing and implementing modeling strategies to enhance decision-making in drug discovery and development. It involves designing, analyzing, and interpreting quantitative pharmacology studies, collaborating with cross-functional teams, and mentoring junior scientists. The role requires expertise in PK/PD and PBPK modeling, experience with relevant software, and a PhD in a related field.

What you'd actually do

  1. Serve as the Discovery PKPD project leader for genetic medicines programs, including ASOs, siRNA, LNP-mediated delivery, gene therapy (AAV and non-viral vectors), and antibody-siRNA conjugates (ARC).
  2. Develop and implement modeling strategies that enhance decision-making for genetic medicines inform translational research strategies.
  3. Design, analyze, and interpret quantitative pharmacology and PK/PD studies.
  4. Collaborate effectively with scientists within and outside the functional area to integrate PK/PD into team strategy and contribute to project team discussions, guiding key go/no-go decisions with quantitative approaches.
  5. Communicate quantitative findings both internally and externally through scientific publications, conference presentations, and cross-functional forums.

Skills

Required

  • PhD in Pharmacokinetics/Pharmacodynamics, Pharmacology, Pharmaceutical Sciences, Biomedical engineering, or a related subject area
  • 5+ years of relevant industry or CRO experience in translational and/or mechanistic PKPD modeling
  • Experience with empirical or mechanistic PK/PD modeling
  • Experience with DMPK and translational PK/PD modeling
  • Experience with relevant modeling and simulation software (NONMEM, mrgsolve, MATLAB, Monolix, SimCYP, PKSim, or equivalent)
  • Experience working effectively in a cross-functional, matrixed collaborative environment

Nice to have

  • Therapeutic area expertise within neuroscience
  • Experience with PKPD or PBPK modeling applied to oligonucleotide therapeutics (ASO, siRNA), LNP delivery platforms, gene therapy (AAV or non-viral), and/or antibody-siRNA conjugates (ARCs)
  • Understanding of the outstanding disposition, intracellular delivery, tissue distribution, and Pharmacodynamics and durability of nucleic acid-based therapeutics
  • Excellent self-management, organizational skills, and ability to manage multiple programs simultaneously
  • Publication record in peer-reviewed journals in quantitative pharmacology, genetic medicines, or related fields

What the JD emphasized

  • PhD in Pharmacokinetics/Pharmacodynamics, Pharmacology, Pharmaceutical Sciences, Biomedical engineering, or a related subject area with experience applying quantitative approaches, with at 5 or more years of relevant industry or CRO experience in translational and/or mechanistic PKPD modeling.
  • Experience with empirical or mechanistic PK/PD modeling to support drug discovery and/or development.
  • Experience with DMPK and translational PK/PD modeling to support interspecies scaling, human dose projections, and first-in-human study design.
  • Experience with relevant modeling and simulation software such as NONMEM, mrgsolve, MATLAB, Monolix, SimCYP, PKSim, or equivalent platforms.
  • Experience with PKPD or PBPK modeling applied to oligonucleotide therapeutics (ASO, siRNA), LNP delivery platforms, gene therapy (AAV or non-viral), and/or antibody-siRNA conjugates (ARCs).