J&J Family of Companies Scientist, Pharmacometrics in Beerse, Belgium
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Scientist Clinical Pharmacology & Pharmacometrics to be located in Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The role of the Pharmacometrics (PM) Scientist within Global Clinical Pharmacology (GCP) is to apply and promote GCP 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, Project Matrix teams, GCP and PM Leaders.
The PM Scientist 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.
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 GCP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
Accountabilities with assistance from senior members of the group:
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 PM Scientist will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
Assist GCP 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), POC, dose-finding and Ph3 studies), including the support for regulatory and filing activities.
Perform literature searches and summarize PKPD 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 PM analyses.
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 GCP and PM Leaders with ad-hoc PM analyses.
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.
Required Knowledge and Skills:
PhD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. Ph.D. degree or equivalent, with 0-3 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 1-2 years of relevant experience.
Understanding of overall process of drug development and the overall pharmaceutical R&D process.
Has established a level of expertise and scientific reputation through publications and/or presentations.
Drug development experience in one or multiple Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
Demonstrated understanding of model based drug development (MBDD), physiologically based pharmacokinetics/pharmacodynamics (PBPKPD), and biostatistics principles and tools (e.g., Simcyp, NONMEM, or Winnonlin) and demonstrated ability to apply these tools to enable rational and efficient drug development.
Understanding of PK, PD, PK/PD, and Translational Medicine.
Knowledge on biologics PK/PD modeling would be great plus.
Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately.
Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).
Up to 5% travel will be required both domestic and international.
Janssen Pharmaceutica N.V. (7555)