Associate Director, Clinical Pharmacology and Pharmacometrics
Company: Disability Solutions
Location: Spring House
Posted on: September 19, 2023
Janssen Research & Development, LLC is recruiting for an
Associate Director, Clinical Pharmacology and Pharmacometrics (CPP)
to be located in Spring House, PA, Titusville, NJ or Raritan, NJ.
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.
- Developing and executing CP development strategy in supporting
the selection of the right dose-regimen, in the right population,
using the relevant biomarkers and the right endpoint to achieve
differentiation and develop a CP package that enables global
- Accountable for all CP trial design, analysis of data,
reporting and interpretation of results.
- Design and execution of appropriate modeling plans along with
the Pharmacometric scientist assigned to the project.
- Entertain strong interactions with opinion leaders beyond
Janssen R&D, with a goal to represent CPP and influence the
scientific and regulatory environment.
- Conducting hands-on pharmacokinetic and
pharmacokinetic-pharmacodynamic analysis for drug development
- Contribute to the required components of regulatory submissions
and be responsible for responding to regulatory authority
- Will drive early alignment on key development questions where
CP principles could be applied.
- Conduct methodological research and effectively apply
state-of-the-art scientific/technical knowledge to projects.
- Introduce new approaches to problem-solving, process
enhancements, and improvement of efficiencies.
- Keep up-to-date knowledge of model-based drug development with
a focus on Clinical pharmacology, biopharmaceutics, PKPD & other
related analytical sciences including implementation of innovative
methods to preclinical research, translational sciences and
- Attend governance meetings, as necessary, ensure that CP plans
are flawlessly executed, and on time for efficient
- Provide and arrange training and presentations on innovative CP
approaches across the R&D organization, ensuring awareness and
adequate knowledge about CPP capabilities and expertise within the
- Plan, conduct, and/or provide oversight of PK and PK/PD
analyses and reporting
- Devise clinical pharmacology strategy including design of Phase
I clinical pharmacology studies and/or use of alternative modeling
- Manage and/or supervise operational elements of CPP
- Develop key product differentiation strategies based on a
compound's key attributes and relevant therapeutic landscape
- Apply appropriate regulatory (eg: FDA, EMA, PMDA, ICH etc)
guidelines and define regulatory strategy for CP and prepare CP
contributions to regulatory documents including IBs, IND's,
briefing books, submission packages, responses to health authority
questions, and other regulatory documents. Represent CP in relevant
external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA,
Advisory Committee meetings).
- Participate in the evaluation of potential business development
- Stay abreast of clinical pharmacology, MIDD, analysis
methodology and overall drug development process, including
regulatory guidance, and methods in modeling and simulation by
engaging with the scientific community (e.g., publishing,
presenting at meetings, participating in special interest groups
within professional societies, etc.).
- Assist in process improvement initiatives and SOP development
Keywords: Disability Solutions, Philadelphia , Associate Director, Clinical Pharmacology and Pharmacometrics, Executive , Spring House, Pennsylvania
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