Jobs · Management · Indiana

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

BioSpace · Indianapolis, IN · 1 mo ago
Management$177k–$308k/yrFull-time

Key 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 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 contribute to project team discussions, guiding 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 space and neuroscience space.

Basic Qualifications

  • PhD in Pharmacokinetics/Pharmacodynamics, Pharmacology, Pharmaceutical Sciences, Biomedical engineering, or a related subject area with experience applying quantitative approaches, with at least 5 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 working effectively in a cross-functional, matrixed collaborative environment.

Additional Skills/Preferences

  • Make a purposeful impact with real patient outcomes – See your scientific contributions translate directly into better medicines for patients, with the opportunity to influence strategy and decisions that meaningfully improve lives worldwide.
  • Visible commitment to mentorship, sponsorship, and career growth – You will mentor and be mentored within a culture that actively invests in scientific leadership development, sponsorship, and progression for diverse talent across technical and people-leader tracks.
  • 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.
  • Publishation record in peer-reviewed journals in quantitative pharmacology, genetic medicines, or related fields.

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