Jobs opportunity at Merck (US) Quantitative Pharmacology and Pharmacometrics group

Dear all, The Quantitative Pharmacology and Pharmacometrics (QP2) group at Merck is now hiring at 3 levels: Senior Scientist, Associate Principal Scientist, and Principal Scientist. Qualified candidates will be hired at the level commensurate with their experience. Merck sponsors work visas for qualified candidates. Please find below the job description. *Location*: West Point, PA; Upper Gwynedd, PA; Kenilworth, NJ; Rahway, NJ; Boston, MA. *Online application: *please visit http://www.merck.com/careers/ - Senior Scientist, R3 (QUA005204) - Associate Principal Scientist, R4 (QUA005203) - Principal Scientist, R5 (QUA005218) *Senior Scientist, R3 (QUA005204) * Senior scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities, and inform dose selection and go/no-go decisions. Senior Scientists work in collaboration with more experienced scientists, and are expected to develop expertise in one or more scientific areas necessary to performing primary responsibilities including: - Being or supporting the lead representative for QP2 on drug/vaccine development teams - Framing critical drug development questions for optimizing model-based development - Developing and executing translational PK/PD approaches, population pharmacokinetic models, exposure-response and stratification biomarker models, QSP and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses. Senior Scientists are expected to develop a comprehensive understanding of global regulatory expectations for small molecules, biologics, and/or vaccines, including support for regulatory documents (INDs, CSRs, CTDs), and agency interactions. The Senior Scientist is a talented modeler and quantitative drug developer with a strong, integrated understanding of the strategic elements of drug discovery and development, and leads the combined efforts of QP2 & the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). In addition, Senior Scientists demonstrate leadership, communication, and collaboration with QP2 leadership and key functional areas to create an aligned, quantitative framework decisions of drug development teams. *Education Minimum Requirement: * - Ph.D. or an MS with a minimum 4 years years of experience in a similar role in pharmaceutical drug development or academia and with a record of increasing responsibility and independence. - Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics , computational biology/chemistry, chemical/biomedical engineering, or a related field. *Preferred Experience and Skills:* - Proficiency in quantitative analyses, modeling and simulation, and data exploration. - Experience in noncompartmental analyses and in modeling and simulation of PK, population PK, and PK/PD. - Familiarity with nonlinear mixed-effect modeling and the use of standard pharmacometric software (e.g. NONMEM, R, Matlab, etc.). - Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in interdisciplinary teams. *Associate Principal Scientist, R4 (QUA005203)* Associate Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities, and inform dose selection and go/no-go decisions. Associate Principal Scientists perform job duties independently with minimal supervision, are capable of supporting or leading QP2 efforts on drug/vaccine development programs, and of authoring strategic documents. Associate Principal Scientists are expected to have or be developing expertise in several scientific key areas for QP2, including: - Serving as an expert representative for QP2 on drug/vaccine development teams - Framing critical drug development questions for optimizing model-based development - Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response (PK/PD) models, stratification biomarker models, QSP and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses - Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings The Associate Principal Scientist is a skilled modeler and a quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development, and leads the combined efforts of QP2 & the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). In addition to the responsibilities described above, Associate Principal Scientists demonstrate excellent leadership and communication, and collaborate with PPDM and other functional area leaders to create an aligned, quantitative framework impacting strategies and decisions of drug development teams, and to provide scientific/strategic leadership and influence on drug development teams. *Education Minimum Requirement:* - Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics , computational biology/chemistry, chemical/biomedical engineering, or a related field. - Ph.D. with a minimum 3 years OR an MS with a minimum 7 years of experience in a similar role in pharmaceutical drug development or academia, with a record of increasing responsibility and independence. *Preferred Experience and Skills:* - An excellent record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry. - Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, statistics, and hands-on computer modeling skills. - Proficiency with the use of one or more of the following software packages: NONMEM, R, Matlab, SPlus, WinNonLin, Phoenix. Experience with NONMEM and with the statistical software package R is strongly preferred. - Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in and lead interdisciplinary teams, are critical. *Principal Scientist, R5 (QUA005218)* Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities, and inform dose selection and go/no-go decisions. Principal Scientists perform job duties independently with minimal supervision, and mentor others to develop similar capabilities. They lead QP2 efforts on drug development programs, and author strategic documents. Principal Scientists are expected to have or be developing expertise in several scientific key areas for QP2, including: - Serving as an expert representative for QP2 on drug/vaccine development teams - Applying functional area knowledge to frame critical drug development questions for optimizing model-based drug development - Strong ability to develop/execute and guide/mentor others on translational PK/PD models, population pharmacokinetic models, exposure-response (PK/PD) models, stratification biomarker models, QSP and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses - Maintaining, and helping others develop and maintain, a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings - Scientific and/or supervisory oversight of a group of scientists The Principal Scientist is a skilled modeler and a quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development, and leads the combined efforts of QP2 & the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). In addition to the responsibilities described above, Principal Scientists demonstrate outstanding leadership, communication, and collaboration with key functional areas to create an aligned, quantitative framework impacting strategies and decisions of drug development teams, and to provide scientific/strategic leadership and influence on drug development teams. *Education Minimum Requirement: * - Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field. - Ph.D. with a minimum 7 years OR an MS with a minimum 11 years and with a record of increasing responsibility and independence. *Preferred Experience and Skills:* - An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry. - Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, statistics, and hands-on computer modeling skills. - Proficiency with the use of one or more of the following software packages: NONMEM, R, Matlab, SPlus, WinNonLin, Phoenix. Experience with NONMEM and with the statistical software package R is strongly preferred. - Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in and lead interdisciplinary teams, are critical. - Experience overseeing the work of other PhD scientists is desirable. Merck Culture: Merck & Co., Inc. Kenilworth, NJ USA, is known as MSD outside the United States and Canada. Our business is preserving and improving human life. We also work to improve animal health. All of our actions must be measured by our success in achieving these goals. We value, above all, our ability to serve everyone who can benefit from the appropriate use of our products and services, thereby providing lasting consumer satisfaction. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Regards, Malidi -- ***************************************************** web: https://www.linkedin.com/in/malidi-ahamadi-40834b11 http://www.maths.leeds.ac.uk/~malidi/ "In the end, we will remember not the words of our enemies, but the silence of our friends." Martin Luther King, Jr. ***************************************************