Principal Scientist, Quantitative Pharmacology and Pharmacometrics
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
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 biologics, 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 areas, 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 and, stratification biomarker models, quantitative system pharmacology (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
- Overseeing a group of scientists (in a scientific and/or supervisory role)
- Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities
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 and the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Principal Scientists demonstrate outstanding leadership and communication skills. They collaborate within QP2 and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.
- Master or equivalent degree with at least 11 years of experience in in a similar role in pharmaceutical drug development or academia
- Ph.D. or equivalent degree with at least seven years of experience or a Pharmaceutical Doctor or equivalent degree with at least nine years of experience in a similar role in pharmaceutical drug development or academia
- Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
- Proficiency in R, Matlab, SAS, or other similar programing language
- 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
- Experience in performing population PK / PKPD and non-compartmental analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)
- Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
- Scientific understanding of biopharmaceutical and ADME properties
- Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
- Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Pharmacokinetics/Drug Metab
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck