Principal Research Scientist Information Technology (IT) - Indianapolis, IN at Geebo

Principal Research Scientist

Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
The position will represent Global PK/PD department and provide PK/PD scientific and technical leadership in the drug discovery, development and commercialization process. The Principal Research Scientist position requires experienced scientists with a PhD preferably in the area of pharmacokinetics/pharmacodynamics. The Principal Research Scientist position would require demonstration of 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:
Responsible for developing PK/PD sections of both early and late stage development team plans.
Lead preparation of Phase I, II, and III study protocols.
Provide scientific interpretation of conventional and population
PK/PD analyses and preparation of study reports.
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.
Additional Skills/Preferences:
10 or more years experience in pharmaceutical sciences or commensurate experience in Pharmaceutical Sciences, Pharmacology, or similar scientific discipline.
Some travel required.
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 non-compartmental 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.
Knowledge and experience in the area of Pharmacokinetics/Pharmacodynamics area and its role in drug research and development.
Expertise in PK/PD and population modeling and simulation.
Working knowledge of software such as NONMEM, SAS, S-Plus and WINNONLIN is required.
Additional Information:
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
Apply online at: https://xjobs.brassring.com/TGWebHost/jobdetails.aspx?partnerid=25428&siteid=5645&Areq=11099BREstimated Salary: $20 to $28 per hour based on qualifications.

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