Associate Scientific Director, Pharmacometrics.
Company: Johnson & Johnson
Posted on: January 9, 2022
Janssen Research & Development, L.L.C., a Johnson & Johnson
company, is recruiting an Associate Scientific Director,
Pharmacometrics that can be located at any Janssen facility in the
US such as Springhouse, PA, Malvern/Chesterbrook, PA, Raritan, NJ,
Titusville, NJ, San Diego/La Jolla, CA, South San Francisco, CA,
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat and
cure disease inspires us. We bring together the best minds and
pursue the most promising science.
We are Janssen. We collaborate with the world for the health of
everyone in it. Learn more at www.janssen.com and follow us
@JanssenGlobal. Janssen Research & Development, LLC is part of the
Janssen Pharmaceutical Companies.
As the Associate Scientific Director, you will develop and
implement advanced pharmacokinetic [PK] and pharmacodynamic [PD]
modeling and simulation (M&S) activities related to the
research, design, implementation, data analysis, interpretation,
reporting, and publication of studies for products in any phase of
You will support product development as Pharmacometrics Leader by
defining the dose-concentration-pharmacological effect
relationships of drugs using M&S methodologies. You will
supervise and conduct pharmacometric analysis and contribute to
drug development and the advancement of science both internally and
externally with minimum supervision. Additional responsibilities
include the generation and review of pharmacometric documents
related to regulatory submissions, preparing responses to Agency
questions and preparing for and/or attending meetings with
Regulatory Agencies or Advisory Committee Meetings.
Responsible For (But Not Limited To)
- Perform basic and clinical disease research, with a focus on
Oncology/Hematology (small molecules, biologics, and other novel
modalities such as cell therapy and gene-therapy).
- Perform population PK and PK/PD analysis for key dose/regimen
selections and regulatory submissions.
- Use innovative computer M&S techniques to formulate various
clinical trial design scenarios and outcome analyses.
- Conduct sophisticated PK/PD M&S research with emphasis on
mechanism-based modeling techniques, systems biology and disease
progression models using data acquired at various development
stages or using literate searched data.
- Develop & review study designs, writes analysis plans &
reports, analyses and interprets PK/PD data and results.
- Lead pharmacometric outsourced work; Review and supervise
outsourced PK/PD related activities.
- Find opportunities and ways to address drug development
questions/issues that qualify to be addressed with mixed effects
modeling or mechanistic modeling.
- Serve as technical expert for the Pharmacometrics organization
in the application of sophisticated PK/PD and disease modeling
principles, as well as in mechanism-based concepts and
- Actively maintain relationships and collaborate with colleagues
within or outside the Clinical Pharmacology and Pharmacometrics
organization and J&J at large
- Help to establish and maintain external collaborations with
Academic groups active in a variety of therapeutic areas
- Act as a trainer and a mentor of junior staff within the
- M.S. degree or equivalent in Pharmaceutical Sciences,
Pharmacology, Engineering, Statistics, Data Science, Bioinformatics
or Biological Science related field and at least 7 or more years'
experience of pharmaceutical development experience in various
aspects of modeling and simulation -OR- PhD or equivalent in
Pharmaceutical Sciences, Pharmacology, Engineering, Statistics,
Data Science, Bioinformatics or Biological Science related field
with at least 5 or more years' experience in pharmaceutical
industry or academia is preferred
- Hands-on experiences with population approach in describing
PK/PD systems with various types of data is required.
- In-depth knowledge of at least on of the following areas:
preclinical or clinical pharmacokinetics, drug metabolism, PK/PD
modeling principles and statistics is required.
- Experience with at least one of the following software: NONMEM,
R, Matlab, Monolix, simCYP and/or other M&S software is
- Detailed knowledge of planning, conducting, evaluating and
reporting PK/PD studies in R&D is required
- The ability to perform basic and clinical disease research,
with a focus on Oncology/Hematology compounds is preferred
- Experience with biologics drug development is preferred
- Experiences with Quantitative Systems Pharmacology (QSP) or
Machine Learning (ML) is preferred but not required
- The ability to multi-task and prioritize assignments,
establishing courses of action for self and others to ensure that
work is completed efficiently and in a timely manner (planning,
organizing and time management) is preferred
- Self-motivated with the ability to work independently with
minimal direction is required
- The ability to translate creative and innovative ways into the
solution of problems and the timely advancement of projects is
- Excellent communication and social skills are required
- Experience working with cross-functional teams is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, age, national origin, or protected
veteran status and will not be discriminated against on the basis
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-Massachusetts-Boston, North
America-United States-Massachusetts-Cambridge, North America-United
States-New Jersey-Raritan, North America-United
States-Pennsylvania-Chesterbrook, North America-United
States-Pennsylvania-Malvern, North America-United
States-Florida-Titusville, North America-United
States-California-San Diego, North America-United
States-California-South San Francisco, North America-United
Janssen Research & Development, LLC (6084)
Keywords: Johnson & Johnson, Titusville , Associate Scientific Director, Pharmacometrics., Executive , Titusville, Florida
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