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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Designs and conducts absorption, distribution, metabolism, and excretion (ADME) research on compounds, drug agents and metabolites in pre-clinical and/ or clinical development. Using a physicochemical approach, attempts to compile various data such as absorption and excretion rates and drug agent half-life in order to establish pharmacokinetic profiles of new chemical and/or molecular entities as well as determining the optimum and safe dosage forms for compounds that have been determined to have indications for various disease groups. Responsible for developing protocols and/or preparing study documentation and findings to support domestic and international submissions of new drugs. May include modeling and simulation. May conduct studies using parametric optimization approach. Manages research related to absorption, distribution, metabolism, and elimination of drugs in both animals and humans for a therapeutic area, product line or program. Works closely with toxicology to document drug exposure in safety studies. Conducts bioanalytical research on drug agents and metabolites in clinical studies, including management of studies conducted in outside labs. Using pharmacokinetics, compiles data such as absorption and excretion rates in order to establish optimal and safe dosage rates. Serves as liaison with marketing, conducting analytical and kinetic studies on new dosage regimens and/or new dosage forms. Participates in and/or leads multidisciplinary teams together with scientists from other units in Novartis; may work with external partners. Leads a lab and/or a project or technology area, integrating independent experimental work to drive achievement of goals with increasing efficiency. Builds increasingly broad scientific/technical/development toolkit for self and team or deepens own technical/scientific specialty and enables Division community in own areas of expertise. Influences and drives projects using broad, up-to-date knowledge of scientific/technical/development discipline or area of specialization, with developing people leadership skills or deep expertise in one or more scientific/technical areas. Uses broad understanding of the project and drug discovery pipeline and leads own team through collaboration and curiosity or connect to matrix community surrounding specific area of deep expertise to generate and answer key scientific/technical questions.Minimum requirements Ph.D. in pharmaceutical sciences with emphasis on biopharmaceutics and pharmacokinetics or related sciences. Preferably 2-3 years of experience in biopharmaceutics, including modeling and simulation. Hands on experience with as physiologically-based pharmacokinetic (PBPK) modeling tools such as Simcyp, GastroPlus, in addition experience with modeling software such as Monolix, R, Phoenix, Nonmem, is a plus. Good written and verbal communication skills are also expected. This role would provide strong insights into developing ideal options to formulation strategy. The modeling and simulation activities conducted under this role provide direction towards development of ideal formulation to bridge the clinical service form.,
Keyskills :
researchapihplcprocess developmentvalidationmodelingsimulationdrug discoverymodeling toolsclinical trialstherapeutic area