Director - Principal Scientist - Johnson & Johnson - Spring House

Description
Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring a Principal Scientist in the Mechanism Based Drug Disposition (MBDD) group to be located in Spring House, PA.
Janssen Research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.

The candidate is expected to play a leading role as a study director interfacing between chemistry, biology and safety, driving DMPK strategies in relation to their area of expertise around projects from early discovery through to the clinic as well as play a key role guiding modeling and simulation within the organization, guiding mechanistic in vitro studies as well as in vivo studies in the study director/project rep. capacity.

In guiding such studies, the study director will be expected to use advanced modeling techniques to help quantify the appropriate biological processes. Such approaches may include (but will not be limited to) the use of advanced modeling techniques to help (a) predict human PK profile (including the quantification of uncertainty around such predictions) (b) quantify the exposure / response relationship needed to quantify “efficacy” and to guide dose selection (c) help guide in vivo experimental design of both PK exposure studies as well as pharmacodynamic end points (d) help quantify and derisk any exposure related AE issues (e) help determine quantifiable in vitro in vivo extrapolation relationships across lead series.

In addition, the candidate is expected to help define global strategies around PK prediction. Such approaches include allometric scaling, PBPK, and other approaches across all sites. Specifically,the candidate will help define a cross-site coherent PK prediction strategy based on the physicochemical properties as well as the proposed clearance mechanism of the compound, including both potential DDI and TDI risks. Such strategies are expected to include the critical evaluation of in vitro platforms. Specifically, the candidate is expected to help define and characterize and guide the appropriate use of in vitro systems for various clearance pathways (phase I, phase II, renal, biliary clearance and so forth). In developing strategies around in vitro in vivo extrapolation (IVIVE) approaches for PK prediction, the candidate is also expected to play a leading role in helping Janssen evaluate the use of next generation in vitro systems, including as “organ on a chip” (liver, kidney and so forth) platforms and their use in pharmacokinetic predictions as well as pharmacodynamic / toxicologic endpoints.

Qualifications

Ph.D. in Pharmaceutical Sciences or a related discipline with minimum of 5 years post-doctoral experience within the pharmaceutical industry. Demonstrated experience in the field of study design and modeling (i.e., scholarly publications and presentations at national/international conferences) is also required. A good understanding of basic drug metabolism issues is highly desirable. Strong background in molecular biology is preferred. Good communication and presentation skills are a must. Good organizational and problem-solving skills are also needed. Must work effectively in a matrix team environment.

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