PKPD Research Leader

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POST DATE 9/8/2016
END DATE 10/8/2016

A New Beginning - Genesis 2 Indianapolis, IN

Company
A New Beginning - Genesis 2
Job Classification
Full Time
Company Ref #
29680035
AJE Ref #
576121516
Location
Indianapolis, IN
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Doctoral Degree

JOB DESCRIPTION

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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. PKPD Research LeaderThe 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.CompensationBase Salary - $130,000 to $190,000Benefits - FullRelocation Assistance Available - YesBonus Eligible - YesInterview Travel Reimbursed - YesCandidate Details7+ to 10 years experienceMinimum Education - Doctorate DegreeWillingness to Travel - NeverLocation: IndianapolisAlso, please understand this may take time for both of us working together to help advance your career. I will do my best for you and never charge you anything for our time and efforts.In all cases we always have several jobs not yet published on the WWW, listed on linkedin or posted to our company website.Many full job descriptions and base salaries in your field of experience can be viewed in various sections on -