Janssen Research & Development, L.L.C., a Johnson &
Johnson company, is recruiting a Scientist in Global Clinical Pharmacology to be
located in: Raritan, NJ, Titusville, NJ and/or Spring House, PA.
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
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
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
The Therapeutic Area (TA) Scientist Global Clinical Pharmacology (GCP) role
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 senior scientist in the group, various stakeholders, QS-Project Matrix
teams, CP and PM Leaders. With oversight, the TA Scientist GCP can also execute
the day-to-day operations for the clinical pharmacology aspects of the assigned
The TA Scientist GCP 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.
- With guidance from senior members of the group, 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
- Assist CP and PM Leaders with the execution of scientifically robust and
efficient clinical pharmacology strategies for NME and/or development
- 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 TA Scientist GCP will translate quantitative knowledge into
strategic opportunities with key stake holders to drive development along
the model-based drug development principles.
- Assist CP 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).
- Help with design of Phase I
Clinical Pharmacology studies.
- Manage operational elements of
GCP studies with respective project CP 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
- 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 CP and PM Leaders with
ad hoc analyses, not limited to non-compartmental analyses in support of Phase
effectively in matrix environment, managing CP deliverables in accordance
with timelines and overall project goals.
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:
- MS, PharmD,
PhD or equivalent degree in Pharmaceutical Sciences, Clinical
Pharmacology, Biomedical Engineering, or relevant Biological Sciences.
Ph.D. degree or equivalent, with 0-1+ years of relevant experience
(including postdoctoral studies)or a MS or PharmD degree or equivalent,
with 3+ years of relevant experience performing progressively advanced
- Has established a level of expertise and scientific reputation
through publications and/or presentations is preferred
- Has a background to influence the drug
development in one or multiple Therapeutic Areas is preferred.
- Has an understanding of model based drug
development (MBDD), biopharmaceutics classification system (BCS), and knowledge
of biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM)
and demonstrated ability to apply these tools to enable rational and efficient
drug development is required.
or working knowledge of US, European, and Asian (including BRIC countries)
regulatory requirements and guidelines is preferred.
- Understanding of PK, PD, PK/PD,
and Translational Medicine is required.
- Ability to interpret PK and PKPD results and prepare presentations
to illustrate findings accurately is required.
basic and or working knowledge of disease processes and mechanisms, available
treatment paradigms, and patient populations within assigned Therapeutic Area is
United States-New Jersey-TitusvilleOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function