Dear all,
Johnson & Johnson is looking for a Senior Scientist, Clinical Pharmacology to
join the Team, located in Spring House, PA. Do you have Understanding of PK, PD
and PK/PD? Are you interested in Model Informed Drug Development? This may be
the role for you! Share, Contact Me or Apply:
https://jobs.jnj.com/jobs/2105888522W?lang=en-us&previousLocale=en-USply:
https://jobs.jnj.com/jobs/2105888522W?lang=en-us&previousLocale=en-US
Key Responsibilities:
* 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.
* Translate quantitative knowledge into strategic opportunities with key
stake holders to drive development along the model-based drug development
principles.
* Collaborate with pharmacometric leaders on modeling and simulation
activities in drug development programs. Perform and/or liaise for modeling and
simulation analysis of preclinical and/or clinical data.
* Execute 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 PK and PK/PD, and (2) requirements for the clinical
pharmacology regulatory submission packages and submission processes.
* Represent clinical pharmacology function in multi-disciplinary clinical
teams (depending on experience).
* Represent Clinical Pharmacology Function in the regulatory meetings (e.g.
pre-IND, EoP1, EoP2, NDA/BLA filing etc.), with the assistance of the senior
member as appropriate.
* Carries out functional responsibilities in accordance to applicable SOPs,
regulatory requirements and Johnson & Johnson Credo principles
Qualifications:
* PhD or equivalent advanced degree is required, in Pharmaceutical
Sciences, Clinical Pharmacology, Biomedical Engineering/Bioinformatics, or
relevant Biological Sciences, with a minimum of 2 or more years of
post-graduate relevant experience, with a keen interest in drug development.
* Working knowledge of small and/or large molecule drug development.
* Drug development experience in Immunology (preferred) and/or other
Therapeutic Areas.
* Have experience analyzing data describing biological or PK/PD systems,
preferably using a non-linear mixed effects modeling approach.
* Understanding of model-based drug development, biostatistics principles
and modelling tools (e.g., NONMEM, R, Python, Phoenix NLME, SimCYP,
Gastro-Plus, MATLAB, SAS, or similar software) and the ability to apply these
tools to enable rational and efficient drug development
* Good written and communication skills.
Thanks,
Yan Xu, Ph.D
Clinical Pharmacology and Pharmacometrics
Janssen R&D - Pharmaceutical companies of Johnson & Johnson
[email protected]
www.janssen.com