Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, (Oncology TA) Clinical Pharmacology. This position is based in Raritan, New Jersey with consideration given to Springhouse, 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. 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.
The Senior Scientist, Oncology (TA) role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply and promote Clinical Pharmacology knowledge, including pharmacokinetics/ pharmacodynamics analyses, DMPK understanding 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, Quantitative Sciences (QS)-Project Matrix teams and Pharmacometrics (PM) Leader. With oversight, the Scientist may also function as a CP Leader on the Compound Development Team (CDT) and execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs within the Clinical Pharmacology and Pharmacometrics Department.
The Oncology (TA) Senior Scientist can directly impact the operational results as they focus on investigation and characterization of how drugs interact with biological systems or diseases so that they can be used safely and effectively, and with the appropriate pharmaceutical formulation.
- 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. Working closely with the senior members, the Scientist will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Collaborate with CP and PM Leaders on modelling and simulation activities in drug development programs. Perform and/or liaise for modelling 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).
- Collaborate with CP and PM Leaders on the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates.
- 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.
- Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles. Design Phase I Clinical Pharmacology studies.
- Manage operational elements of Clinical Pharmacology studies.
- Perform literature searches and summarize the findings.
- A PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences OR an M.S. or PharmD degree or equivalent, with a minimum of one (1) year of relevant experience is required. Consideration will be given to candidates with documentation indicating that all the requirement for the PhD. Have been met prior to the start date.
- Understanding of PK, PD, PK/PD, and Translational Medicine is required.
- Ability to interpret PK and PK/PD results and prepare presentations to illustrate findings accurately is required.
- Basic understanding of DMPK and overall process of drug development and the overall pharmaceutical R&D process is required.
- Drug development experience in Oncology (preferred) and/or other Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously.
- Demonstrated understanding of model-based drug development (MBDD), biostatistics principles and modelling tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development.
- Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).
This position is based in Raritan, New Jersey with consideration given to Springhouse, PA. and may require up to 10% domestic and international travel.
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-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)