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Skills
Assay Developmentunmatched
Assaysunmatched
Bioinformaticsunmatched
Biologyunmatched
Biomarkersunmatched
Biotech and Pharmaceuticalunmatched
Clinical Practices/Protocolsunmatched
Contingency Plansunmatched
Documentationunmatched
Drug Developmentunmatched
Drug Discoveryunmatched
Geneticsunmatched
Genomicsunmatched
Intellectual Property (IP)unmatched
Medicineunmatched
Molecular Biologyunmatched
Pharmacovigilanceunmatched
Project Portfolio Management (PPM)unmatched
Regulationsunmatched
Research & Development (R&D)unmatched
SAPunmatched
Scientific Principlesunmatched
Statisticsunmatched
Time Managementunmatched
Translational Researchunmatched
Vendor/Supplier Managementunmatched
Description
ScientistLooking for Personalized Medicine and Translational Science Expert, for a temporary contract position accountable for executing Personalized and Predictive Medicine (PPM) strategies, serving as the point person for scientific advice on portfolio compounds.Will work collaboratively with interfaces across the entire company to effectively deliver PPM value to the drug discovery and development process.The successful candidate will lead studies to evaluate genomic and other biomarkers for association with drug response and safety, as well as lead genomic characterization of drugs' mode of action and toxic genomics.Integrating PPM activities effectively in the assigned clinical development programs in collaboration with all relevant functions.Advising R&D functions as an expert in all PPM-related aspects of scientific principles, clinical protocol development, regulatory guidance, intellectual property (IP), assay development, commercial value, etc.Executing Pharmacogenomics and biomarker studies, drafting relevant documentation and being accountable for its on-time executionEnsuring selection of cost-effective and appropriately validated assays; manage vendors in experimental set-up and implementation in clinical trialsCollaboratively developing the statistical analysis plan (SAP), or equivalent, for PPM projects within and parallel to the relevant clinical development programProactively identify challenges and develop contingency plans as appropriateParticipation in PPM and clinical development team meetingsPhD/MS in human genetics, genomics, molecular biology, computational biology, similar2+ years' experience in pharmacogenomics and/or biomarker applied research, preferably in the pharmaceutical settingKnowledgeable in the field of genetics, bioinformatics and statistical analysis and interpretation of multivariate Pharmacogenomics and/or biomarker data