• Pharmacometrician and Senior / Jobs in Germany - 23751359

  • Boehringer Ingelheim India Pvt Ltd
  • Germany
  • Save Job
  • 7 - 15 Years
  • Posted : above 1 month

Job Description:

This job is posted for an extended time / permanently as we have a continous demand for this profile

Pharmacometrician

The Pharmacometrician will perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval with the support of his/her supervisor He/she will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy with the support of his/her supervisor

Tasks & responsibilities

Develop PMx strategy and contribute to the clinical development plan, and implement model-informed drug discovery and development (MID3) in clinical development projects with support of supervisor
Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (eg, non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development)
Ensure timely delivery of PMx internal documents with support of supervisor (eg, dataset specification, PMx analysis plan, and PMx report)
Ensure timely delivery of documents where PMx is co-author with support of supervisor (eg, clinical development plan, pediatric investigational plan, submission documents)
Represent PMx in clinical development teams and in initiatives and working groups with support of supervisor (eg, process harmonization)
Organize and manage projects with external organizations with support of supervisor (eg, academic institutions or CROs)

Requirements

Master Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 2 - 6 years of experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred
0 - 3 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia with PhD or MD, preferred
Proficiency in applying PMx software (eg, NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology)
Basic knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

Senior Pharmacometrician

The Senior Pharmacometrician will independently perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval They will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy, independently

Tasks & responsibilities Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration (eg, non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development)
Develop PMx strategy and clinical development plan, and implement model-informed drug discovery and development (MID3) in clinical development projects
Ensure timely delivery of PMx internal documents (eg, dataset specification, PMx analysis plan, and PMx report)
Ensure timely delivery of documents where PMx is co-author (eg, clinical development plan, pediatric investigational plan, submission documents)
Represent PMx in project teams (eg early clinical development team and clinical pharmacology and biomarker team), and regulatory meetings
Continuously evaluate and implement novel PMx methods and approaches

Requirements Masters Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 4 - 12 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia or; MD/PhD from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with minimum of 2 - 9 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred
Proficiency in applying PMx software (eg, NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology)
Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines
1 - 4 years relevant experience in working in clinical development teams, preferred

Principal Pharmacometrician

The Principal Pharmacometrician will act as an internally and externally recognized Pharmacometrician and/or integrator in (early) clinical development teams by developing pharmacometrics (PMx) strategy, perform PMx analyses and represent PMx and/or TMCP in project teams and regulatory meetings They will continuously and consistently develop, implement and promote innovative PMx methodologies/approaches and provide consultancy and expert advice for other pharmacometricians

Task & responsibilities

Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (eg, non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development)
Develop PMx strategy and clinical development plan, and implement model-informed drug discovery and development (MID3) with focus on complex international development projects
Ensure timely delivery of PMx internal documents (eg, dataset specification, PMx analysis plan, and PMx report)
Ensure timely delivery of documents where PMx is co-author (eg, clinical development plan, pediatric investigational plan, submission documents)
Represent PMx in project teams and regulatory meetings
Act as integrator in early clinical development teams (ECD integrator)
Represent Translational Medicine and Clinical Pharmacology in core teams and decision body meetings
Develop, implement and promote (increase visibility of) innovative PMx methodologies and approaches in multiple therapeutic areas
Lead or participate in internal and external initiatives/working groups (eg, process harmonization, IMI calls, ISoP groups)

Requirements

Masters Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 7 - 15 years of experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia or; MD/PhD in from an accredited institution Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or relevant area of focus with a minimum of 4 - 9 years of experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred
Proficiency in applying PMx software (eg, NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology)
Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines
Minimum of four years relevant experience in working in clinical development teams, preferred

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Teaching/Education
Role : Teacher
Salary : As per Industry Standards
Deadline : 01st Apr 2020

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