Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 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.
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. Qualifications:
- 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 experience OR an MS with a minimum 11 years experience and with a record of increasing responsibility and independence.
- The educational and experience requirements listed above are required
- 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
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