Associate Director, Clinical Pharmacology & Pharmacometrics (Cpp)

at J&J Family of Companies in Boise, Idaho, United States

Associate Director, Clinical Pharmacology & Pharmacometrics (CPP) - 2306155645W

Description

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is looking for an Associate Scientific Director, Pharmacometrics to be in Spring House PA or Raritan, NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

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.

The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote Clinical Pharmacology expertise including the design of Clinical Pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. The Associate Director CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The AD CPP leader can independently execute the day-to-day operations for the Clinical Pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.

Main Accountabilities:

• Devise the Clinical Pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development. Translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-informed drug development principles.

+ Plan, perform, and/or provide oversight for appropriate analyses (e.g., non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data) of preclinical-clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.

• Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use

• Responsible for planning and delivery of scientifically robust and efficient Clinical Pharmacology strategies for development candidates.

• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.

Other Accountabilities & Tasks

• 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 alternate modeling approaches.

• Manage and/or supervise operational elements of CPP studies.

+ Develop key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape

+ **D