Merck Principal Scientist, Quantitative Pharmacology and Pharmacometrics in Rahway, New Jersey
Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
Principal Scientists in the Pharmacometrics group at the department of Quantitative Pharmacology and Pharmacometrics 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 pharmacometric/QP2 representative on drug/vaccine development teams
Framing critical drug development questions and develop modeling and simulation strategies for optimizing model-based drug development
Developing and executing on translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/bio-pharmaceutical 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 (Investigational New Drugs, Clinical Supplies Requestor, Common Technical Documents), 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
Ph.D. or equivalent degree with ≥ 7 years of experience) OR (a PharmD or equivalent degree with ≥ 9 years of experience) OR (an MS or equivalent degree with ≥ 11 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/bio-statistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
Proficiency in NONMEM, Monolix, R, Matlab, Statistical Analysis System, or other similar programming 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 state-of-the-art analyses using standard pharmacometric software
Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
Scientific understanding of biopharmaceutical and Absorption, Distribution, Metabolism and Excretion 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
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R53333
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