Jobs · OTHR · Indiana

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

BioSpace · Indianapolis, IN · Today
OTHR$177k–$308k/yrFull-time

About the role

At Lilly, we unite caring with discovery to help make life better for people around the world. This role supports the Pharmacokinetics/Pharmacodynamics and Pharmacometrics (PMx) organization, which provides leadership and technical expertise to advance the discovery and development of new medicines from preclinical lead molecule identification to clinical post-drug approval. The goal is to identify and develop the right drug with the right dose for the right patient using model-informed drug research and development (MIDD) approaches.

We are seeking a Scientific Director experienced in mechanistic PK, PK/PD, and/or PBPK modeling of novel modalities to contribute to Lilly’s drug discovery and development efforts in genetic medicines.

Responsibilities

  • 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).
  • Develop and implement modeling strategies that enhance decision-making for genetic medicines and inform translational research strategies.
  • Design, analyze, and interpret quantitative pharmacology and PK/PD studies.
  • Collaborate effectively with scientists within and outside the functional area to integrate PK/PD into team strategy and guide key go/no-go decisions with quantitative approaches.
  • Communicate quantitative findings both internally and externally through scientific publications, conference presentations, and cross-functional forums.
  • Mentor junior scientists and contribute to the growth of PKPD modeling capabilities within the genetic medicines and neuroscience spaces.

Requirements

  • PhD in Pharmacokinetics/Pharmacodynamics, Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, or a related subject area with experience applying quantitative approaches.
  • At least 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 computational modeling and simulation software such as NONMEM, mrgsolve, MATLAB, Monolix, SimCYP, PKSim, or equivalent platforms.
  • Experience working effectively in a cross-functional, matrixed collaborative environment.

Skills

  • Previous people management experience is preferred, including management in a matrix environment.
  • 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 disposition, intracellular delivery, tissue distribution, 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.

Benefits

  • Visible commitment to mentorship, sponsorship, and career growth within a culture that invests in scientific leadership development.
  • Eligibility to participate in a company-sponsored 401(k) and pension plan.
  • Vacation benefits and eligibility for medical, dental, vision, and prescription drug benefits.
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
  • Life insurance and death benefits.
  • Certain time off and leave of absence benefits.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
  • Company bonus (depending on company and individual performance).

Pay

The anticipated wage for this position is $177,000 - $308,000.

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