Two pharmacometrics specialists in PK/ PD modelling and simulation

Two pharmacometrics specialists in PK/ PD modelling and simulation - Readvertisement 

Would you like to help us create a strong function for quantitative assessments in close collaboration with competent 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 and PK/PD modelling and simulation? 
 
Then come and join us at the Danish Medicines Agency!   
 
The Danish Medicines Agency has a vision   
The Danish Medicines Agency is Denmark’s national regulatory authority for the licensing and monitoring of medicinal products, medical devices and clinical trials. Our mission is to secure effective, safe and accessible medicines and safe medical devices for the benefit of society.   
 
We are around 400 employees based in Copenhagen and through the European Medicines Agency (EMA) we collaborate with our colleagues from the 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.   
 
Our vision is to become a medicines agency in European top class. This means that you will be a key driver in the European collaboration, secure a strong international position and contribute to making Denmark a leading life science nation.  
 
The Danish Medicines Agency offers a multidisciplinary workplace   
The position is located in the Biostatistics function in our new Medical Evaluation division. In this division, we will gather our medical resources from the licensing and pharmacovigilance divisions. The new Biostatistics function will strengthen our biostatistics and pharmacometrics efforts and establish an efficient data-analytical environment. The function will cooperate with all the relevant groups of the organisation. 
 
Your profile  
You have a relevant master’s degree in healthcare or statistics. Research experience from e.g. a PhD programme in modelling and simulation is desired. You have work experience in PK/PD modelling, including population PK/PD and evaluation of models, and preferably experience from the pharmaceutical industry or a strong research environment.   
 
To apply for this position, you need to: 

• have an interest in and a flair for assessing clinical research, including pharmacokinetics/dynamic analyses and studies, bioequivalence studies and data, population PK/PD and clinical trial simulations etc.   
• have an eye for details and be able to adopt a pragmatic approach 
• have excellent interpersonal skills, stay focused, maintain strong attention to detail and meet deadlines   
• be motivated by working in an interdisciplinary and international environment where English is the working language, and you speak and write English proficiently  
• have in-depth knowledge of relevant software, e.g. NONMEM NLME, Phoenix etc.  

 
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. 
 
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 characterised by dedication, humour 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 programme tailored to your needs so that you can improve and develop your competencies. 
 
In the Biostatistics function, 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.  
 
A working day in our Biostatistics function 
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 as to their 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 next meeting of the European Committee for Medicinal Products for Human use.    
 
You are making preparations for a scientific advice meeting with a company. A pharmaceutical company plans to submit an application for the authorisation of a new medicinal product, but they are unsure whether the planned clinical development project is sufficient. They have obtained advice from the US drug regulatory authority and now they are paying visits to various drug regulatory authorities in Europe. You provide pharmacometric advice on the study design of their phases IIA and IIB programme, particularly the dose-response design.   
 
Conditions of employment   
The position is covered by the terms of the collective agreement between the Danish Ministry of Finance and the Danish Confederation of Professional Associations with the possibility of negotiating qualification supplement. In addition to the salary a monthly contribution to a pension fund is added (17.1% of the salary).   
 
The position is full time with start 1 March 2017 or as soon as possible after this date. Your work place will be the Danish Medicines Agency, Islands Brygge. 
 
Further information   
For more information please contact Director General Thomas Senderovitz, tel. +45 9359 6479 / +45 4488 9595. 
 
You can find information about the Danish Medicines Agency on www.lmst.dk.
 
Application   
Apply online via "Ansøg" link no later than 27 January 2017. The application should include motivation letter, current CV and copy of relevant diplomas.  
 
Interviews are scheduled to be held in weeks 5-6.   
 
We encourage all interested candidates to apply, regardless of age, gender, religious affiliation or ethnic background. 
 

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