Principal Scientist Pmetrics
Il y a 2 heures
Antwerp, Flanders, Belgique
Able Too Work
Temps plein
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pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at jnj.com ( . /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function: /h3 pDiscovery Pre-Clinical/Clinical Development /p h3Job Sub Function: /h3 pPharmacokinetics Pharmacometrics /p h3Job Category: /h3 pScientific/Technology /p h3All Job Posting Locations: /h3 pBeerse, Antwerp, Belgium /p h3Job Description: /h3 pThe 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. /p pThe 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. /p h3You will be responsible for: /h3 h3Accountabilities with guidance from senior members of the group: /h3 ullipConduct 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. /p /lilipWriteanalysis plans reports,define datarequirements,conductanalyses, perform quality control (QC) checks,and interpret PK/PD data and results. /p /lilipWorkeffectively in a matrix environment, managing pharmacometricsdeliverablesin accordance withtimelines and overall project goals. /p /lilipContribute to the development of new methodology and/or applications of pharmacometrics. /p /li /ul h3Other Accountabilities Tasks: /h3 ullipPresentinternally and atexternalscientificmeetings; prepare and publish manuscripts in peer reviewed scientific journals; mayparticipateinspecial interest groups within professional societies. /p /lilipAssist in process improvement initiatives, software validationandother technology improvements. /p /lilipCarryout functional responsibilitiesin accordance withapplicable SOPs, departmental processes and Regulatoryrequirements,and Johnson Johnson Credo principles. /p /li /ul h3Education and Experience
Requirements:
/h3 ulliPh.
D. degree or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio
- Engineering or Biological Sciences, with2+years of post-doctoral experience or M.
S. degree with 4+ years of relevant experience. /li /ul h3Minimum Technical Knowledge and
Skills:
/h3 ullipWorking knowledge of PK PK/PD modeling and simulation (pharmacometrics) concepts and methods. /p /lilipHands-on knowledge of pharmacometrics modeling software (NONMEM and/or Monolix, R). /p /lilipUnderstanding of the overall drug development process including MIDD and the Pharmaceutical RD process. /p /lilipWorking knowledge ofregulatory requirements and guidelines. /p /lilipGood oral and written communication skills. /p /li /ul pEstimated both domestic and international travel of about 5% of time. /p h3Required
Skills:
/h3 h3Preferred
Skills:
/h3 pClinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research /p h3The anticipated base pay range for this position is: /h3 p€79 800,00
- €137 770,00 /p h3Benefits: /h3 pIn addition to base pay,
we offer
the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover,
we offer
vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement,
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at jnj.com ( . /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function: /h3 pDiscovery Pre-Clinical/Clinical Development /p h3Job Sub Function: /h3 pPharmacokinetics Pharmacometrics /p h3Job Category: /h3 pScientific/Technology /p h3All Job Posting Locations: /h3 pBeerse, Antwerp, Belgium /p h3Job Description: /h3 pThe 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. /p pThe 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. /p h3You will be responsible for: /h3 h3Accountabilities with guidance from senior members of the group: /h3 ullipConduct 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. /p /lilipWriteanalysis plans reports,define datarequirements,conductanalyses, perform quality control (QC) checks,and interpret PK/PD data and results. /p /lilipWorkeffectively in a matrix environment, managing pharmacometricsdeliverablesin accordance withtimelines and overall project goals. /p /lilipContribute to the development of new methodology and/or applications of pharmacometrics. /p /li /ul h3Other Accountabilities Tasks: /h3 ullipPresentinternally and atexternalscientificmeetings; prepare and publish manuscripts in peer reviewed scientific journals; mayparticipateinspecial interest groups within professional societies. /p /lilipAssist in process improvement initiatives, software validationandother technology improvements. /p /lilipCarryout functional responsibilitiesin accordance withapplicable SOPs, departmental processes and Regulatoryrequirements,and Johnson Johnson Credo principles. /p /li /ul h3Education and Experience
Requirements:
/h3 ulliPh.
D. degree or equivalent in Pharmaceutical Sciences, Pharmacometrics, Chemical/Biomedical/Bio
- Engineering or Biological Sciences, with2+years of post-doctoral experience or M.
S. degree with 4+ years of relevant experience. /li /ul h3Minimum Technical Knowledge and
Skills:
/h3 ullipWorking knowledge of PK PK/PD modeling and simulation (pharmacometrics) concepts and methods. /p /lilipHands-on knowledge of pharmacometrics modeling software (NONMEM and/or Monolix, R). /p /lilipUnderstanding of the overall drug development process including MIDD and the Pharmaceutical RD process. /p /lilipWorking knowledge ofregulatory requirements and guidelines. /p /lilipGood oral and written communication skills. /p /li /ul pEstimated both domestic and international travel of about 5% of time. /p h3Required
Skills:
/h3 h3Preferred
Skills:
/h3 pClinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research /p h3The anticipated base pay range for this position is: /h3 p€79 800,00
- €137 770,00 /p h3Benefits: /h3 pIn addition to base pay,
we offer
the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover,
we offer
vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement,