Posting for Eli Lilly

From: Bonny Beesley Date: September 30, 2010 technical Source: mail-archive.com
Research Advisor - PK/PD The position will represent Global PK/PD/TS department and provide PK/PD/TS scientific and technical leadership in the drug discovery, development and commercialization process. Candidates for the Principle Research Scientist position will have demonstrated technical capability and leadership in the context of drug discovery, development, and commercialization. They are expected to leverage their science to help drive solutions. Candidates for the Research Advisor will have demonstrated technical capability in the context of drug discovery, development, and commercialization. The role requires leadership on project teams and an ability to integrate data from other disciplines and understand the high level issues affecting the team. They are expected to leverage their science to help drive solutions. The majority of contributions for these positions are at the portfolio level. KEY OBJECTIVES/DELIVERABLES: 1. Responsible for developing PK/PD sections of program and product 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 MINIMUM REQUIREMENTS: * Ph.D in scientific field * 5-10 years experience in pharmaceutical sciences or commensurate experience in Pharmaceutical Sciences, Pharmacology, or similar scientific discipline * Expertise in PK/PD and population modeling and simulation * Knowledge and experience in the area of Pharmacokinetics/Pharmacodynamics area and its role of in drug research and development * Working knowledge of software such as NONMEM, SAS, S-Plus and WINNONLIN is required . ADDITIONAL SKILLS/PREFERENCES: * Excellent communication, presentation, and written skills * Able to effectively work with senior management while balancing quality and speed in complex situations * 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 * Knowledge of the role of PK/PD in drug development and FDA/ICH requirements for drug registration * Familiarity with experimental study design OTHER CONSIDERATIONS: * Some travel required. Please apply directly: https://careers.peopleclick.com/careerscp/client_lilly/external/gateway. do?functionName=viewFromLink&jobPostId=29147&localeCode=en-us