Senior Scientist, Clinical Pharmacology, Established Products
- Titusville, NJ
Janssen R&D is recruiting for a Senior Scientist - Clinical Pharmacology, Established Products, located in Raritan, NJ, Titusville, NJ, or Spring House, PA.
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.
The Senior Scientist - Established Products Clinical Pharmacology & Pharmacometrics (CPP) role is to apply and promote CPP knowledge, including pharmacokinetics/pharmacodynamics analyses and principles of model-based drug development in the programs for all stages of drug development ranging from pre-New Molecular Entity (NME) declaration through Post-Marketing support, in collaboration with various stakeholders, QS-Project Matrix teams, CPP and PM Leaders. With oversight, the Established Products, Senior Scientist CPP can also execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs.
The Senior Scientist, Established Products can directly impact the operational results, as they are focused on investigation and characterization of how drugs interact with biological systems or diseases so they can be used safely and effectively, and with the appropriate pharmaceutical formulation. Responsibilities include:
- Applies the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes.
- Assist CPP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
- Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. With assistance from senior members, the Established Products, Senior Scientist CPP will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Assist CPP and PM Leaders with modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) and POC studies).
- BS, MS, PharmD, PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences.
- Ph.D. degree or equivalent, with 2+ years of relevant experience (including postdoctoral studies)or a MS or PharmD degree or equivalent, with 3+ years of relevant experience or a BS degree with 5+ years of experience performing progressively advanced duties.
- Help design Phase I Clinical Pharmacology studies. Question Do you have experience developing Phase I Clinical Pharmacology studies
- Manage operational elements of CPP studies with respective project CPP Leaders.
- Perform literature searches and summarize the findings.
- Help design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project.
- Contribute to preparation of monographs, INDs and other documents as applicable to support clinical studies.
- Remain current with clinical and drug development information 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.
- Support CPP and PM Leaders with ad hoc analyses, not limited to non-compartmental analyses in support of Phase I studies.
- 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 deliver of value/impact.
- Drug development experience in one or multiple Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
- 5 to 10% Travel may be required
- Demonstrated understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient 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, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
United States-New Jersey-Raritan-
United States-New Jersey-Titusville, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
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