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[NMusers] Career Opportunity - Senior Research Scientist, Pharmacology - Janssen R&D US

From: Zhenling Yao <zhenlingyao_at_gmail.com>
Date: Tue, 16 Jul 2019 12:45:54 -0400

Dear NMusers,

Janssen R&D Clinical Pharmacology and Pharmacometrics (CPP) is seeking a
senior scientist to join our team. The position is based in Spring House,
Pennsylvania.



*Senior Research Scientist, Pharmacology, R&D, Requisition no. 1672190410*

The Clinical Pharmacology and Pharmacometric (CPP) Department of Janssen
Research & Development, L.L.C., a Johnson & Johnson company, is seeking a
highly motivated individual to join Clinical Pharmacology (CP) Immunology
group at Senior Scientist level. This individual is to apply and promote
CPP knowledge, including pharmacokinetics (PK)/ pharmacodynamics (PD)
analyses, translational modelling 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. Depending on the
experience, this individual may 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.

· 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.

· Perform 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).
Provide PKPD guidance to Phase 2-3 studies.

· Execute scientifically robust and efficient clinical pharmacol=
ogy
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.

· Carries out functional responsibilities in accordance to appli=
cable
SOPs, regulatory requirements and Johnson & Johnson Credo principles

· Perform literature searches and summarize the findings.

· Contribute in monographs, INDs and other documents as applicab=
le to
support clinical studies and regulatory filings (e.g. NDA/BLA).

· Represent Clinical Pharmacology Function in the regulatory mee=
tings
(e.g. pre-IND, EoP1, EoP2, NDA/BLA filing etc.) with the assistance of the
senior member as appropriate.

· 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 CP 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 deliverabl=
es 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.

*Qualifications*

· PhD or equivalent degree in Pharmaceutical Sciences, Clinical
Pharmacology, Biomedical Engineering, or relevant Biological Sciences of
relevant experience OR MS or PharmD degree or equivalent, with a minimum of
2 years of relevant experience, with keen interest in drug development.

· Understanding of PK, PD, PK/PD, and Translational Medicine.

· Have experience analyzing data describing biological or PK/PD
systems, preferably using a non-linear mixed effects modeling approach.

· Ability to interpret PK and PK/PD results and prepare presenta=
tions
to illustrate findings accurately.

· 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 Immunology (preferred) and/or o=
ther
Therapeutic Areas and the ability to handle contributions to multiple
clinical pharmacology programs, simultaneously.

· Demonstrated understanding of model-based drug development,
biostatistics principles and modelling tools (e.g., NONMEM, R, Phoenix
NLME, R, SimCYP, Gastro-Plus, MATLAB, SAS, or similar software) and
demonstrated ability to apply these tools to enable rational and efficient
drug development.

· Working knowledge of clinical and regulatory landscape, diseas=
e
processes and mechanisms, available treatment paradigms, and patient
populations within assigned Therapeutic Area(s).





External Applicants & J&J Contractors:

• Apply through the J&J careers site.

• Posting link:
https://jobs.jnj.com/jobs/1672190410?lang=en-us&previousLocale=en-US

Internal Employees:

To view/bid on the position, internal candidates (and displaced employees
within 12 months of termination) can go to:www.oursource.biz > My Career &
Development > My Next Step > Search by Requisition #: 1672190410



Received on Tue Jul 16 2019 - 12:45:54 EDT

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