Location: Spring House
Company: Johnson And Johnson
and report pharmacokinetic (PK) and pharmacodynamic (PD) analyses. Conduct advanced PK/PD modeling research with emphasis on mechanism-based modeling techniques, systems biology and disease progression models. 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. Support clinical development through model-informed drug development (MIDD), with guidance
from senior clinical pharmacology and pharmacometrics (CPP) leaders. Apply regulatory requirements and guidance in drug development undertakings. Serve as CPP Leader on Compound Development Teams (CDT) under supervision, and collaborate with various stakeholders to execute day-to-day operations in the clinical pharmacology domain of assigned programs.
Programs may cover all phases of drug development, ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support. Perform population PK/PD analysis in support of regulatory submissions. Identify opportunities and ways to address drug development questions and issues via linear or nonlinear mixed effects modeling.
Use standard PK software to integrate PK/PD and evaluate optimal doses and regimens.
Requirements: Ph. D. degree in medical Sciences, Clinical Pharmacology, Biomedical Engineering or related Biological Sciences field and 1 year of experience in the job offered or a Senior Scientist-related occupation. Position requires experience with : 1. Clinical pharmacology principles - pharmacokinetics and pharmacodynamics ; 2. Translational medicine (integrating knowledge of nonclinical and clinical data) ; 3. Pharmacokinetic analysis tools including NONMEM ; 4. Statistical data analysis tools including R ; 5. Interpreting pharmacokinetic and pharmacodynamic results ; and 6.
Regulatory guidance in conducting and analyzing data from clinical pharmacology studies to support drug development. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. ]
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