Pharmacokinetics (PK) assessor sought for clinical data

Do you want to be part of our team that masters the pharmacokinetic assessment of clinical trial data? Do you want to help drive the European agenda regarding drug approval in clinical pharmacokinetics? Then perhaps you are the one we are looking for here at the Danish Medicines Agency.

Your primary tasks

Assessment of clinical pharmacology in drug applications with a focus on an in-depth evaluation of human pharmacokinetic (PK) data in the application and in the product information (SmPC). The assessment is written up in reports

• Join the assessment of the overall clinical benefit-risk profile for new medicines in collaboration with, among others, doctors, biostatisticians and toxicologists, including contributing to the understanding of clinical pharmacology
• Advise companies through national Advice schemes and Scientific Advice schemes at the European Medicines Agency (EMA)
• Participation in peer review teleconferences, meetings with companies and meetings with other European drug authorities

Your everyday life with us

As a PK assessor of clinical pharmacology you will primarily work with the assessment of PK/ADME data, related to registration applications' clinical documentation material. This can be data from studies describing PK parameters in healthy volunteers, in patients or in special patient populations, description of bioavailability, mass balance/metabolism, drug interactions (in vitro and in vivo) as well as biomarkers. You will be involved in the assessment of both chemical and biological medicines.

The work is based on European and international guidelines as well as a scientific assessment/analysis of the submitted documentation. Your written assessment will form part of the overall authority report for a given medicine. The report is part of the basis for the final decision on whether a medicine can be approved, must be rejected or whether additional data should be obtained.

Your work also includes advising the pharmaceutical industry on questions regarding regulatory requirements. You will join an exciting cross-disciplinary team with pharmacometricians, doctors, pharmacists, toxicologists and biostatisticians, and you will have contact with external experts and colleagues in other countries' drug agencies.

We support each other and pay attention to each other's well-being. We have a good collegial atmosphere with an informal tone, initiative and lots of good humor.

Your education, experience and personal qualifications

You have a Master's level education, e.g., pharmacist, human biologist, engineer, chemist or physician, preferably supplemented with a PhD or other postgraduate education in pharmacokinetics or clinical pharmacology.

You have relevant professional experience, e.g., from pre-clinical or clinical drug development, which has given you a solid understanding of pharmacokinetics and knowledge of bioanalysis, ADME studies and drug interactions.

You must be motivated to work interdisciplinary in an international environment and therefore, in addition to Danish, you must master written and spoken English at a high level.

You must be able to work independently, take responsibility and thrive with varied tasks. Since we receive a lot of data and information you must be able to combine and balance the detail-oriented with the pragmatic and maintain an overview. We expect you to have good teamwork skills, and to be able to work systematically and purposefully.

We offer

You will become part of a dynamic professional environment characterized by skilled and engaged colleagues. You will get exciting tasks with professional challenges and insight into the regulatory system within drug approval. You will be part of a workplace with an informal working climate, filled with engagement, humor and mutual respect. The Danish Medicines Agency has a central location on Islands Brygge, close to the S-train, metro and buses.

We also offer

• Internal training
• Focus on the balance between an exciting working life and leisure/family life and the need for home working
• Opportunity for continuing education within relevant areas
• Opportunity for influence through networks at national and European level

About the Section for Toxicology, Pharmacokinetics and Biology

The position is placed in the section “Toxicology, Pharmacokinetics & Biologie”, which consists of a total of 26 employees, of whom three work with human pharmacokinetics PK and 2-3 with clinical modelling.

Together with colleagues from other sections, we are responsible for evaluating applications for approval of new medicines in the EU, submitted to the European Medicines Agency and to the Danish Medicines Agency, and for advising the pharmaceutical industry on regulatory requirements.

Read more about us and our work at Lægemiddelstyrelsen.dk .

About the employment

You will be employed under the applicable collective agreement between the Ministry of Finance and academics in the state or another applicable collective agreement, depending on your educational background.

At the Danish Medicines Agency we make decisions in regulatory cases, and it is important to us that one cannot question our impartiality. Therefore, it is a prerequisite that you do not own shares, parts or interests in a pharmaceutical and/or medical device company. However, you have a grace period to sell them if you currently own employee shares in a pharmaceutical and/or medical device company.

Feel free to contact us

Learn more about the position by calling section head Per Spindler at telephone 21467248.

You can read more about us and our tasks at Lægemiddelstyrelsen.dk .

Are you interested?

Click on "apply for the position" and send us your application with CV and diploma.

We expect to hold interviews in weeks 44-45.