Pharmacometrics Director

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is looking for inventive, motivated and eager scientists to join the Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Team. PK/PD & Pharmacometrics scientists are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval. Our goal is to identify and develop the right drug with the right dose for the right patient through the model-informed paradigm of drug R&D. These emerging scientists will apply PK/PD and pharmacometric approaches to translate from preclinical to the clinical setting by integrating data from multiple subject areas.

This role lets you contribute scientific expertise to model-informed drug discovery. You'll work on trial designs and data interpretation. If you're passionate about making an impact and delivering results, apply today!

We need a dynamic and hardworking scientist who is able to:

• Conduct PK/PD modeling and simulation to advise drug development programs.
• Provide PK/PD/Pharmacometric and scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development approaches.
• Support decision-making through collaboration on cross-functional teams.
• Develop PK/PD sections of clinical development plans.
• Support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data interpretation, and study reports.
• Prepare relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with FDA, EMA, PMDA and other regulatory agencies.
• Mentor other scientists as well as interact, guide and collaborate with academia.
• Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortia.

• PhD and/or MD in relevant scientific field such as pharmacokinetics, pharmacometrics, clinical pharmacology, biological/pharmaceutical sciences, bioengineering, biostatistics
• At least 5 years of relevant work experience.

• Knowledge of relevant modeling and simulation software (e.g. NONMEM, Monolix, R, S-Plus, Phoenix NLME, MATLAB, Berkeley Madonna, Simbiology, SIMCYP, Phoenix WinNonLin, etc.)
• Experience in pharmacokinetics, pharmacometrics, clinical pharmacology, population PK modeling, exposure-response modeling, clinical trial simulation

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