Principal Scientist - PPDM-QUA003635
**Description**
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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 people 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.
Primary responsibilities of Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) include serving as an expert representative for QP2 on drug development teams, developing and executing PK/PD and Modeling & Simulation (M&S;) strategies, and applying functional area knowledge to frame critical drug development questions for optimizing model-based drug development. QP2 Principal Scientists apply PK/PD and M&S; approaches to design and evaluate clinical and preclinical study data, characterize the kinetics of drug absorption and disposition (ADME), assess the dynamics of drug effect, and inform dose selection and go/no-go decisions. Principal Scientists also maintain a comprehensive understanding of global regulatory expectations for small molecules and biologics, including authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings. The QP2 scientist is a quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug development (early through late), 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 for impactful decision making on drug development teams. Principal Scientists perform job duties with a high degree independence relative to less experienced scientists, are capable of supporting and/or leading more complex drug development programs, author strategic documents, and have responsibility for scientific oversight of staff across the group. Principal Scientists are expected to have or be developing expertise in several key scientific areas for QP2, including: translational and clinical PK/PD analyses, clinical trial simulations, disease state modeling, clinical outcomes modeling, comparator modeling, absorption/biopharmaceutical modeling, adaptive design, clinical utility indices, translation of biomarkers to clinical outcomes, enrollment modeling, etc. They are also capable of leveraging this expertise, in collaboration with other PPDM leaders and key functional area partners, to provide scientific/strategic leadership and influence within QP2 as well as outside the department.
****Qualifications****
Education:
* PhD, PharmD, MD or other equivalent degree
**Required:**
* Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, biostatistics, computational biology/chemistry, or a related field.
* A minimum of 5-7 years of experience in a similar role in pharmaceutical drug development, with an exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches, is required.
* Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, statistics, and hands-on modeling skills are highly desirable (including proficiency with non-linear mixed effects modeling and one or more of the following software packages, such as, but not limited to: NONMEM, Matlab, SPlus, R, WinNonlin, SAS.
* Expertise in developing translational models to advance discovery programs is a plus.
* Solid proficiencies in written and verbal communication, interpersonal skills, project management, problem scoping and planning, and the ability to participate in and lead interdisciplinary teams, are critical.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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**Job:** Quantitative Sciences Generic
Job Title:Prin. Scientist, Quant. Sciences
**Primary Location:** NA-US-PA-West Point
**Other Locations:** NA-US-PA-Upper Gwynedd, NA-US-MA-Boston, NA-US-NJ-Kenilworth, NA-US-NJ-Rahway
**Employee Status:** Regular
**Travel:** No
**Number of Openings:** 1
*Req ID:* QUA003635
*Date:* Thu, 13 02 2014 00:00:00 GMT
*Country:* US
*State:* PA
*City:* West Point
*Postal Code:* 19486
*Locale:* en_US