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.