Novartis IVIVC (In Vitro In Vivo Correlation)
Manager- Respiratory (Pharmacy or Life
science)
Job
Description
1000 molecules belong to the department of clinical
development (clinical due diligence and clinical research). You will chip in to
the filling and maintenance of the portfolio by working closely with our
business development team and other partners.
Your responsibilities include, but are not limited
to:
•Responsible for chipping in and driving the
clinical development strategy for respiratory drug products in close
collaboration with the development and project teams. Responsible for review
and update of the clinical development strategy as needed.
•Give good cross-functional understanding and
experience of generic inhaler development and device technology to the project
team. Responsible to work closely with technical development to link the
technical and clinical expertise.
•Be familiar with characteristics of API, excipients
and have understanding which parameters are affecting bioavailability;
Preparation of bioequivalence risk assessment from literature data and in-vitro
data
•Sound understanding of the challenges of the
product and product development, e.g. influence of priming, determinant of in
vitro variability between batches, particle size.
•Able to analyze and interpret in vitro study
results and dossiers. Must have fair knowledge of in-vitro and in-vivo
correlation and device mechanisms of orally inhaled products.
•Validated skills and abilities in quantifying in
vitro determinants influencing in vivo exposures of orally inhaled products and
in batch selection.
•Should have sound knowledge of application of tools
like Win-Nonlin, Gastro-Plus, and IVIVC toolkit.
•Experience with different study types (e.g.
pharmacokinetic studies, therapeutic endpoint studies and scintigraphy studies
(preferable).
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