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 within the field of clinical pharmacokinetics? Then it might be you 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

• Participate in 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 daily life with us

As a PK assessor of clinical pharmacology you will primarily work with the assessment of PK/ADME data related to the clinical documentation material of registration applications. This can be data from studies describing PK parameters in healthy volunteers, in patients or in special patient populations, descriptions of bioavailability, mass balance/metabolism, drug–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 authority's consolidated 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 refused, or whether additional data should be sought.

Your work also includes advising the pharmaceutical industry on authority 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 look out for each other and have an eye for 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 candidate-level degree, e.g., pharmacist, human biologist, engineer, chemist or doctor, preferably supplemented with a PhD or other postgraduate education in pharmacokinetics or clinical pharmacology. You have relevant professional experience, for example 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 across disciplines in an international environment and therefore, in addition to Danish, you must have a high level of written and spoken English.

You must be able to work independently, take responsibility and thrive with a variety of tasks. Since we receive a lot of data and information, you must be able to combine and balance the detailed with the pragmatic and maintain an overview. We expect you to have good collaboration 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 dedicated colleagues. You will have exciting tasks with professional challenges and an insight into the regulatory system for drug approval. You will be part of a workplace with an informal work climate, filled with engagement, humor and mutual respect. The Danish Medicines Agency has a central location at Islands Brygge, close to the S-train, metro and buses.

We also offer

• In-house training
• Focus on balancing an exciting professional life with leisure/family life and the need for home working
• Opportunity for further education and continuing education within relevant areas
• Opportunity for influence through networks at national and European levels

About the Section for Toxicology, Pharmacokinetics and Biology

The position is placed in the section "Toxicology, Pharmacokinetics & Biology", which consists of a total of 26 employees, of which 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 the 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 questions related to authority requirements.

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

About the appointment

You will be employed according to 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 authority cases, and it is important to us that no one can question our impartiality. Therefore, it is a condition that you do not own shares, parts, interests or similar in a pharmaceutical and/or medical device company. You do, however, have a certain period to sell them if you currently own so-called employee shares in a pharmaceutical and/or medical device company.

Feel free to contact us

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

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

Are you interested?

Click on "apply for the position" and send us your application with CV and diploma. We expect to conduct interviews in weeks 44-45.

Application deadline: 22 October