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Sr. Scientist, Pharmacokinetics and Drug Disposition(
Plays a key role as a PK representative in non-clinical and clinical development teams to support drug development and foster a collaborative working environment with colleagues across disciplines by exhibiting appropriate professional and personal behavior.
Plan and perform activities investigating drug ADME, exposure – response relationships, and covariate effects on drug disposition. These activities include study design, protocol development, data analysis and interpretation, topline and report preparation to meet corporate and Drug Safety Evaluation timelines. Analyze PK/PD data and use sophisticated mathematic and statistical modeling and simulation tools to support proof-of-concept, study design and dose selection.
* Ph.D., in Pharmaceutical Sciences or related field at least 4 years of pharmaceutical industrial experience in pharmacokinetics, immunogenicity, protein therapeutics, biomarkers, drug metabolism and pharmacogenomics.
* Proven experience in preclinical and clinical drug development of small molecules and therapeutic biologics
* Scientific publications in area of specialization
Essential Skills and Abilities
* Advanced skills in pharmacokinetics, pharmacodynamics, metabolism, protein therapeutics, immunogenicity, working knowledge of immunoassays, biomarkers and non-invasive imaging technology.
* Effective written and verbal communication skills; strong understanding of regulatory environment to support regulatory and corporate agencies.
* Have demonstrated industry experience from drug discovery through clinical drug development.
* Ability to utilize PK/PD data analysis and modeling/simulation software (such as Phoenix WinNonlin, S-Plus, NONMEM, SAS, etc) and strong ability to collaborate with cross functional areas to meet R&D objectives.
* Ability to work within a diverse workforce.
* Strong scientific and leadership skills with the ability to lead research and development sub-teams and influence and collaborate with leaders in our R&D.
* Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
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