Job Information
Janssen Research & Development, LLC Senior Scientist in Springhouse, Pennsylvania
Employer: Janssen Research & Development, LLC
Job Title: Senior Scientist
Job Code: A011.5288
Job Location: Spring House, PA
Job Type: Full-Time
Job Duties: Promote and apply clinical pharmacology component of clinical trials within the Cardiovascular and Metabolic, Pulmonary Arterial Hypertension, and Neuroscience Therapeutic Areas. Perform 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: Employer will accept a Ph.D. degree in Pharmaceutical 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.
CONTACT: To apply, please send resume to jkim6240@its.jnj.com. Please refer to Job #A011.5288.