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Eli Lilly and Company Principle Research Scientist-PK/PD and Pharmacometrics - R-11720 in Indianapolis, Indiana

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 39,000 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. Were looking for people who are determined to make life better for people around the world.For more than a century, Eli Lilly and Company has been committed to making life better. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose of making medicines that help people live longer, healthier, more active lives. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe.Passion, curiosity, creativity, and persistence are qualities of our research area. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? Confident and compelling communication will be key in this role.The Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly is looking for creative, motivated and hardworking scientists to join our group. The scientists in our group are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval. Optimally identifying and developing the right drug with the right dose for the right patient and living the model-informed drug research and development (MIDD) paradigm is the goal.Our organization seeks a multifaceted, experienced, and driven scientist who is able to:Provide PK/PD/Pharmacometric and scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development strategies; apply the appropriate PK/PD and pharmacometric approaches to translate from preclinical to the clinical setting by integrating data from multiple fields.Expect and understand the high-level issues affecting the drug discovery/development process and help derive at effective solutions. Support decision-making through collaboration on cross-functional teams.Develop PK/PD sections of program and product team plans/strategies as project leader.Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.Responsible for preparation of 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 within the department and in other areas as well as interact, teach and collaborate with academia.Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortiaIn summary, in this exciting scientific leadership role, you will have opportunities to be a part of the project team applying model-informed discovery and development approach to innovative medicine that will improve the lives of patients around the world.Basic Qualifications:PhD and/or MD in relevant scientific area such as biological/pharmaceutical sciences, bioengineering or related field.At least 5 years of experience from industry, regulatory, consulting or academia with exposure to industry.Additional Preferences: Excellent understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.Additional Information:This position can be located in Indianapolis, USA, or in a remote work environment.Eli Lilly and Company, Lilly USA, LLC and our wholly o