Janssen Research & Development, L.L.C., a Johnson &
Johnson company, is recruiting a Senior Scientist in Global
Clinical Pharmacology to be located in: Raritan, NJ, or
Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical needs in
oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please
visit http://www.JanssenRnD.com for
position is responsible for the development and execution of Pharmacometrics
(PM) activities related to the research, design, implementation, data analysis,
interpretation, reporting, and publication for products in any phase of
development. Additional responsibilities include the generation and review of
clinical pharmacology documents related to regulatory submissions, preparing
responses to Agency questions and preparing for and/or attending meetings with
Regulatory Agencies and Advisory Committee Meetings.
- Establish and
elaborate pharmacometric strategies to support model informed drug
development for projects at all stage of development
- Execute pharmacometrics strategies by applying
innovative methods to integrate data of pharmacokinetics, pharmacodynamics,
biomarkers, clinical outcomes, patient characteristics, disease mechanisms and
performing simulations to facilitate quantitative decision making
with multi-disciplinary project groups and work in close collaboration
with partners in Clinical Pharmacology, Biostatistics and Programming, and
- Author and review pharmacometrics-related sections in
clinical development plan, study protocols, study reports, and regulatory
- Maintains state-of-the art knowledge of modelling
techniques and methodologies and establish scientific credibility in the
company and in external scientific communities
- Lead by example and coach Associate scientists, Sr.
associate scientists and Scientists
- Carry out
functional responsibilities in accordance with applicable SOPs and
installation and validation of new and existing software used by
- Assist in
process improvement initiatives and SOP development
- Ph.D. Degree
or equivalent, minimum 3 years of relevant experience is required or M.S.
Degree, PharmD, or equivalent and at least 6 years of experience is
hands-on knowledge of data handling packages (SPLUS / R / SAS) is required
- Proficient hands-on
knowledge of Nonlinear Mixed effect modeling software packages is
- A fundamental
understanding of clinical drug development is required.
of ICH and other relevant regulatory guidelines and regulations is
- This position is requiring up to 5% travel.
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
A little about us:
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