Pharmacometrics specialist in PK/PD modelling and simulation

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Would you like to help us create a strong function for quantitative assessments in close collaboration with competent medical doctors and biostatisticians? Would you like to play a part in setting the stage for the assessment of medicinal products and clinical trials? Would you be interested in providing high-level scientific advice? And would you like to contribute to setting the European agenda for the licensing of medicines – with special focus on data analysis, population PK and PK/PD modelling and simulation?

Then come and join us at the Danish Medicines Agency!

About us
The Danish Medicines Agency is Denmark’s national regulatory authority for the licensing and monitoring of medicinal products, medical devices and clinical trials. We are about 570 employees based in Copenhagen. Through the European Medicines Agency (EMA) we collaborate with colleagues from other European drug regulatory authorities. We participate in various professional working parties with other experts, and Denmark has a seat on all the European committees for medicinal products.

The position is located in the Regulatory and Clinical evaluation Unit. The use of modelling and simulation studies are increasing in the central procedures e.g. marketing authorization applications for new medicines in EMA, therefore we want to strengthen the pharmacometric function to establish an efficient data-analytical environment. The pharmacometricians work in close cooperation with the clinical pharmacologists and the medical specialists responsible for evaluation of benefit-risk.

About the job
You assess PK/PD data and clinical data, including models of a new medicinal product submitted by a pharmaceutical company. They have designed a dose-response study and used PK/PD modelling to support the design. You have a number of questions regarding the choice of model and study design.

You are having a conference call with experts from another EU country who also assessed the studies. You have co-authored a report, which all the European countries will be discussing at the forthcoming meeting of the European Committee for Medicinal Products for Human use (CHMP).

Within the Regulatory and Clinical evaluation Unit, you will get the opportunity to increase your experience in the assessment of study designs and clinical data and get thorough knowledge of regulatory authorities’ requirements for the licensing of medicines.

Your education, experience and personal qualifications
You have a relevant master’s degree in pharmacometrics, clinical pharmacology, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology, biomedical engineering, or a related field. Research experience from e.g. a PhD program in modelling and simulation is desired but not required. You have work experience in population PK and PK/PD modelling of clinical data, including use of pharmacometrics software such as NONMEM, Phoenix or Monolix and maybe knowledge of R and SAS. Experience with exposure-response modelling, PBPK modelling or QSP will be an advantage.

To apply for this position, you need to:

  • have an interest in and a flair for assessing data from clinical development. Especially population PK and PK/PD analyses but also simulation of drug-drug interactions, pediatric extrapolation studies, clinical trial simulations etc.
  • be flexible and enjoy a variety of tasks since no marketing authorisation applications are alike.
  • be motivated by working in an interdisciplinary and international environment where English is the working language, and you speak and write English proficiently
You are able to combine and balance attention to details with being pragmatic. You have excellent interpersonal skills and are able to stay focused, maintain the overview and meet deadlines.

What we offer
An international workplace with collaboration partners throughout Europe via the European Medicines Agency. In the longer term, you will get the opportunity to participate in the EMA’s working parties such as the Modelling & Simulation Working Party (MSWP). The MSWP support EMA’s scientific committees and working parties on modelling and simulation and contribute expert advice to Scientific Advice and pediatric investigation plans. In addition, you can contribute to revision of ICH and EMA Guidelines and other regulatory publications within M&S and represent EMA at international conferences and scientific meetings. A great opportunity to set your mark and take active part in the regulatory assessment of medicines.

You will become part of a dynamic and professional environment with competent and energetic colleagues, and you will be offered supplementary and further training within relevant areas. We offer an informal working environment characterized by dedication, humor and mutual respect.

You will have challenging and varied tasks, and you will be using and developing your competencies within a wide range of tasks. You will be offered an individual development program tailored to your needs so that you can improve and develop your competencies.

About the employment
The position as Senior Advisor is covered by the terms of the collective agreement between the Danish Ministry of Finance and the Danish Confederation of Professional Associations.

The position is full time and may be partly home-based.

Further information
For more information please contact Head of Unit (Oncology & Hematology) Doris Hovgaard phone +45 9359 0156 or Pharmacometrician Anne-Mette Hoberg phone +45 9351 8646

You can find information about the Danish Medicines Agency on www.lmst.dk.

Application
Press “apply for the position”. The application should include motivation letter, current CV and copy of relevant diplomas.

Interviews are scheduled to be held in week 36.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Pharmacometrics specialist in PK/PD modelling and simulation

Would you like to help us create a strong function for quantitative assessments in close collaboration with competent medical doctors and biostatisticians? Would you like to play a part in setting the stage for the assessment of medicinal products and clinical trials? Would you be interested in providing high-level scientific advice? And would you like to contribute to setting the European agenda for the licensing of medicines – with special focus on data analysis, population PK and PK/PD modelling and simulation?

Then come and join us at the Danish Medicines Agency!

About us
The Danish Medicines Agency is Denmark’s national regulatory authority for the licensing and monitoring of medicinal products, medical devices and clinical trials. We are about 570 employees based in Copenhagen. Through the European Medicines Agency (EMA) we collaborate with colleagues from other European drug regulatory authorities. We participate in various professional working parties with other experts, and Denmark has a seat on all the European committees for medicinal products.

The position is located in the Regulatory and Clinical evaluation Unit. The use of modelling and simulation studies are increasing in the central procedures e.g. marketing authorization applications for new medicines in EMA, therefore we want to strengthen the pharmacometric function to establish an efficient data-analytical environment. The pharmacometricians work in close cooperation with the clinical pharmacologists and the medical specialists responsible for evaluation of benefit-risk.

About the job
You assess PK/PD data and clinical data, including models of a new medicinal product submitted by a pharmaceutical company. They have designed a dose-response study and used PK/PD modelling to support the design. You have a number of questions regarding the choice of model and study design.

You are having a conference call with experts from another EU country who also assessed the studies. You have co-authored a report, which all the European countries will be discussing at the forthcoming meeting of the European Committee for Medicinal Products for Human use (CHMP).

Within the Regulatory and Clinical evaluation Unit, you will get the opportunity to increase your experience in the assessment of study designs and clinical data and get thorough knowledge of regulatory authorities’ requirements for the licensing of medicines.

Your education, experience and personal qualifications
You have a relevant master’s degree in pharmacometrics, clinical pharmacology, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology, biomedical engineering, or a related field. Research experience from e.g. a PhD program in modelling and simulation is desired but not required. You have work experience in population PK and PK/PD modelling of clinical data, including use of pharmacometrics software such as NONMEM, Phoenix or Monolix and maybe knowledge of R and SAS. Experience with exposure-response modelling, PBPK modelling or QSP will be an advantage.

To apply for this position, you need to:

  • have an interest in and a flair for assessing data from clinical development. Especially population PK and PK/PD analyses but also simulation of drug-drug interactions, pediatric extrapolation studies, clinical trial simulations etc.
  • be flexible and enjoy a variety of tasks since no marketing authorisation applications are alike.
  • be motivated by working in an interdisciplinary and international environment where English is the working language, and you speak and write English proficiently
You are able to combine and balance attention to details with being pragmatic. You have excellent interpersonal skills and are able to stay focused, maintain the overview and meet deadlines.

What we offer
An international workplace with collaboration partners throughout Europe via the European Medicines Agency. In the longer term, you will get the opportunity to participate in the EMA’s working parties such as the Modelling & Simulation Working Party (MSWP). The MSWP support EMA’s scientific committees and working parties on modelling and simulation and contribute expert advice to Scientific Advice and pediatric investigation plans. In addition, you can contribute to revision of ICH and EMA Guidelines and other regulatory publications within M&S and represent EMA at international conferences and scientific meetings. A great opportunity to set your mark and take active part in the regulatory assessment of medicines.

You will become part of a dynamic and professional environment with competent and energetic colleagues, and you will be offered supplementary and further training within relevant areas. We offer an informal working environment characterized by dedication, humor and mutual respect.

You will have challenging and varied tasks, and you will be using and developing your competencies within a wide range of tasks. You will be offered an individual development program tailored to your needs so that you can improve and develop your competencies.

About the employment
The position as Senior Advisor is covered by the terms of the collective agreement between the Danish Ministry of Finance and the Danish Confederation of Professional Associations.

The position is full time and may be partly home-based.

Further information
For more information please contact Head of Unit (Oncology & Hematology) Doris Hovgaard phone +45 9359 0156 or Pharmacometrician Anne-Mette Hoberg phone +45 9351 8646

You can find information about the Danish Medicines Agency on www.lmst.dk.

Application
Press “apply for the position”. The application should include motivation letter, current CV and copy of relevant diplomas.

Interviews are scheduled to be held in week 36.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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