Principal Scientist Pharmacometrics - Hyderabad

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Hyderabad, Andhra Pradesh, India

Job Description:

Clinical Pharmacology & Pharmacometrics (CPP)

Principal Scientist Pharmacometrics - Hyderabad

The Principal Scientist Pharmacometrics position is responsible for the co-development and execution of population pharmacokinetic [PK] , pharmacodynamic [PD], and exposure-response(ER) modeling and simulation activities related to the planning, implementation, analysis, interpretation, and reporting for compounds in development.

Additional responsibilities include the authoring of pharmacometrics documents related to regulatory submissions, preparing responses to Agency questions and contributing to meetings with Regulatory Agencies and Advisory Committee Meetings.

The position is responsible for contributing to the development of Model Informed Drug Development(MIDD)planswith guidance fromsenior members of the group, clinical pharmacology leadersand other stakeholders.

With guidance, thePrincipal Scientistcan execute the day-to-day operations for thepharmacometricanalysesof the assigned programs.

Principal Responsibilities:

Accountabilities with guidance from senior members of the group :


* Conduct population PK, PD, ER analyses to informdose regimen selectionand otherkeydrug development decisions,support the designof clinicalstudies and model-informed drug development plans,andto support regulatory submissions.



* Writeanalysis plans & reports,define datarequirements,conductanalyses, perform quality control (QC) checks,and interpret PK/PD data and results.



* Workeffectively in a matrix environment, managing pharmacometricsdeliverablesin accordance withtimelines and overall project goals.



* Contribute to the development of new methodology and/or applications of pharmacometrics.

Other Accountabilities & Tasks :


* Presentinternally and atexternalscientificmeetings; prepare and publish manuscripts in peer reviewed scientific journals; mayparticipateinspecial interest groups within professi...