The Janssen Research & Development, LLC is recruiting for a Senior Scientist, Clinical Pharmacology at our Springhouse, PA site.
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 Immunology Clinical Pharmacology (CP) Senior Scientist role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology knowledge, including the design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/pharmacodynamics analyses and reporting, and application of principles of model-informed drug development (MIDD) within an Immunology program, with guidance from senior CPP leaders. With oversight, the Senior Scientist CPP can function 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) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned Immunology programs. Programs can be across all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support.
Accountabilities with assistance from senior members of the group:
- Contribute to overall compound 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 and perform appropriate analysis (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.
- Summarize and provide interpretation of results of PK and PKPD analyses with respect to their impact on a development program and clinical use.
- Design and execute scientifically robust and efficient clinical pharmacology strategies for Immunology development candidates.
- Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
- Plan and conduct PK and PK/PD analyses, provide independent QC, and report results in appropriate format (e.g., team presentations, memo, CSR).
- Design Phase I clinical pharmacology studies and clinical pharmacology components of clinical studies.
- Manage operational elements of CPP studies.
- Perform literature searches and summarize the findings.
- Contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents as applicable to support clinical studies and/or programs.
- Expand knowledge of clinical pharmacology, model informed drug development, 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.) and internalize key learnings back to Janssen.
- Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
- Apply relevant technical trainings/learnings to daily responsibilities, with focus of opportunistic delivery of value/impact.