Eli Lilly and Company is looking for an experienced PKPD Scientist for its Indianapolis, Indiana Headquarters. If interested, please apply at https://careers.lilly.com/job/indianapolis/pkpd-research-leader/410/2663084.
Company Overview 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. We're looking for people who are determined to make life better for people around the world. Responsibilities The Principal Research Scientist will represent the Global PK/PD department and provide PK/PD scientific and technical leadership in the drug discovery, development and commercialization process. The position requires experienced scientists with a PhD preferably in the area of pharmacokinetics/pharmacodynamics. The successful candidate will have demonstrated technical ability, proficiency at team work, performance on teams, and ability to understand issues and drive for solutions. The majority of contributions for the position are at the portfolio level. Key Objectives/Deliverables: 1. Responsible for developing PK/PD sections of both early and late stage development team plans 2. Lead preparation of Phase I, II, and III study protocols 3. Provide scientific interpretation of conventional and population PK/PD analyses and preparation of study reports 4. Responsible for preparation of INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs, as well as interactions with regulatory authorities around the globe. Basic Qualifications * Ph.D. in Pharamacokinetics/Pharmacodynamics, Statistics, Bioengineering, Biomedical or related scientific field * 7 or more years of experience in pharmaceutical sciences or commensurate experience in Pharmaceutical Sciences, Pharmacology, or similar scientific discipline Additional Skills/Preferences * Expertise in PK/PD and population modeling and simulation * Knowledge and experience in the area of Pharmacokinetics/Pharmacodynamics area and its role in drug research and development * Working knowledge of software such as NONMEM, SAS, S-Plus and WINNONLIN is required * Proficiency with the theory and application of PK/PD, compartmental and noncompartmental analyses and fundamentals of pharmacostatistical modeling * On the job training or industrial experience with submissions to regulatory agencies * Excellent communication, presentation, and written skills * Able to effectively work with senior management while balancing quality and speed in complex situations * Knowledge of the role of PK/PD in drug development and FDA/ICH requirements for drug registration * Familiarity with experimental study design Additional Information * Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Michael Heathman Head of Global Pharmacometrics Eli Lilly and Company
