PKPD Research Leader

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POST DATE 9/8/2016
END DATE 12/19/2016

A New Beginning - Genesis 2 Indianapolis, IN

Indianapolis, IN
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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. 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.

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.

* 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.

* 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.

Base Salary - $130,000 to $190,000
Benefits - Full
Relocation Assistance Available - Yes
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes

7+ to 10 years experience
Minimum Education - Doctorate Degree
Willingness to Travel - Never
Location: Indianapolis

Also, 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.

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