PhD fellow at the Copenhagen Centre for Regulatory Science

TheCopenhagen Centre for Regulatory Sciences (CORS), Department of Pharmacy isoffering a three-year PhD fellowship in Regulatory Science. The fellowship isfinanced by H. Lundbeck A/S. The fellowship is available from October 1, 2018,or the soonest possible thereafter. 

 

With it Research CORS seeks toimprove the drug regulatory system, by systematically studying its structureand behaviour as well as designing new tools to facilitate regulatorydecision-making. Through improvement of the drug regulatory system, we aim to contributeto an improvement of the health of the society.  

 

Theregulatory system for medicines is intended to protect public health byensuring that only medicines of sufficient quality, safety, and efficacy enterthe market, while at the same time facilitating patient access to neededtherapies without unnecessary delay. It strives to achieve these goals via alarge set of individual regulatory tools. For policy-making in general, andespecially in the health care sector, regulatory decisions need to be fullytransparent, rest on relevant reasoning, and be adaptable in light of newevidence. Therefore, the efficiency of the elements in the regulatory toolbox,as well as any unintended effects of the tools, need to be determined.  

 

We offer an interesting andchallenging job in an international cross-disciplinary research environment.You will become part of a research environment spanning pharmacy, humanities,law, and social science. We strive for academic excellence, collegial respectand freedom tempered by responsibility. 

  

Project description 

Scarcity inpaediatric drug development leads to unlicensed and off-label use of drugs inthe paediatric population, with little reliable evidence on appropriatedosage(s) and alternative routes of administration for children. As a result,there is a potentially increased health risk due to adverse reactions, under-or over-dosing. Both the US and the EU have imposed regulations facilitatingpaediatric drug development, with the objective of improving the health ofchildren. Both the US and the EU regulations provide incentives and imposerequirements on sponsors for the development of medicinal products for thepaediatric population. Currently, the value of the paediatric regulations havemainly been evaluated based on a mere measurement of compliance with thelegislation and the number of medicines evaluated by the Regulatory Authoritiesin individual regions. However, an assessment should ideally also include anevaluation of the acquired knowledge about medication use in the paediatricpopulation, how that knowledge has translated into action and facilitatedaccess of treatments and ultimately a positive impact on public health ofchildren.  Moreover, it is important thatthe regulatory frameworks and systems enable and support medicines developmentin a global context and only few attempts have been made to compare andevaluate the impact of paediatric regulations across regulatory jurisdictions.The objective of this PhD project is to provide insights into the effectivenessof the EU and US paediatric regulations in promoting access to medicines forchildren as well identifying potential barriers of the paediatric regulationsto innovative drug development in general. Ultimately, these analyses shouldserve to provide recommendations for improvements to the global regulatoryframeworks for paediatric medicines development with a focus on the US and theEU.  

 

Principal supervisor 

Professor Marie Louise De Bruin, Department ofPharmacy, University of Copenhagen: 

E-mail: marieke.debruin@sund.ku.dk

Direct phone: +45 35330818. 

Requiredqualifications 

As an applicant you musthave:

  • Master’s degree or equivalent in a relevant field to the proposed work (pharmacy, public health, medicine or other relevant fields). 
  • Ability and enthusiasm to learn quantitative methods within Drug Regulatory Science. 
  • An interest in cross-disciplinary work within Drug Regulatory Science. 
  • Good communication skills in English, both oral and written. 
  • Independent and self-reflective. 

Preferredqualifications 

  • Overall a preferred applicant has an excellent academic track record, and is highly motivated to study issues within Drug Regulatory Science. 
  • Have demonstrated early in his/her career a capacity for excellence.  
  • Make this position his/her number one priority, have a strong work ethics, and be a team player. 

Job descriptionYour key tasks as a PhD fellow at the Faculty are to:

  • Carry out and complete an independent research project under supervision.  
  • Write scientific articles and the PhD thesis on the grounds of your research project.  
  • Complete PhD courses or other equivalent education corresponding to approx. 30 ECTS points.  
  • Obtain experience with teaching and/or other types of dissemination related to your PhD project. 
  • Participate in the undergraduate teaching of students in pharmaceutical sciences.
  • Participate in national and international congresses and scientific meetings.  
  • Obtain experience from an external research institution, preferably abroad.  

Key criteria for the assessment ofapplicants: 

  • Professional qualifications relevant to the PhD programme.  
  • Relevant work experience.  
  • Previous publications including relevant master thesis. 
  • Achieved grade point average.  
  • Other professional activities.  
  • Language skills.  
  • Enterprising approach and skills. 
  • Possess good interpersonal skills. 

Formal requirements 

The successful applicant will berequested to formally apply for enrolment as a PhD student at the Faculty ofHealth and Medical Sciences subject to the rules stipulated in the Ministerialorder on the PhD programme at the universities (PhD order) from the Ministry ofScience, Innovation, and Higher Education and the guidelines for the PhD programme at the Faculty of Health and Medical Sciences

The PhD student is expected to be affiliated to the graduate programme inpharmaceutical sciences, Drug Research Academy.  

Termsof employment 

The position as a PhD fellow is for a 3-year period. 

Salary andother terms and conditions of appointment are set in accordance with theAgreement between the Ministry of Finance and AC (Danish Confederation ofProfessional Associations) or other relevant professional organizations.Depending on seniority, the monthly salary begins around DKK 26,454 (approx.3,550 EUR) (taxable) plus pension. The position is covered by the Job Structurefor Academic Staff at Universities (2013).   

 

Application procedure 

The application, inEnglish, must be submitted electronically by clicking APPLY NOW below and include: 

  • Cover letter stating the interest in and qualifications for the project (max. one page).  
  • Full CV.  
  • Diploma and transcripts of records: Master’s degree diploma (including grade transcripts for bachelor’s and master’s degrees).  
  • Applicants with a Master’s degree from abroad should also enclose a short description of the grading scale used.  
  • Publication list, if applicable.  
  • Other information: Possible references and recommendations.  

Please note that only online applications willbe accepted. 

Deadline for applications 

August 15, 2018. Applicationsreceived later than this date will not be considered.  

 

Post application procedure 

Shortlist: After the expiry of the deadline for applications, the authorised recruitmentmanager selects applicants for assessment on the advice of the AppointmentCommittee. All applicants are then immediately notified whether theirapplication has been passed for assessment by an expert assessment committee.Selected applicants are notified of the composition of the committee and eachapplicant has the opportunity to comment on the part of the assessment thatrelates to the applicant him/herself. You can read about the recruitmentprocess at http://employment.ku.dk.   

Assessment: The selected applications will be assessed according to the Ministerial Orderno. 242 of 13 March 2012 on the Appointment of Academic Staff at Universitiesand the University of Copenhagen’s guidelines 2013. The Assessment Committeemakes a non-prioritised assessment of the academic qualifications andexperience with respect to the mentioned area of research, techniques, skillsand other requirements listed in the advertisement.Please note that the applicant willbe contacted if the assessment committee requires further documentation. 

Interviews will be held withpotential candidates in week 35 or week 38. An answer to the granting of thefellowship can be expected approx. 4 weeks after the deadline. 

Questions 

For furtherinformation, applicants may contact the co-supervisor Assistant ProfessorChristine E. Hallgreen, e-mail: christine.hallgreen@sund.ku.dk, direct phone:+45 3533 7079, orAdministrator Marianne W. Jørgensen, e-mail: marianne.joergensen@sund.ku.dk, direct phone: +45 3533 6449.  

 

You can read more about the Copenhagen Center forRegulatory Science at https://pharmacy.ku.dk/research/cors/

For information on working andliving in Denmark visit ism.ku.dk (International Staff Mobility) and www.workindenmark.dk

 

The University of Copenhagen wishes to reflect the diversity of societyand welcomes applications from all qualified candidates regardless of personalbackground.

APPLY NOW

Part of the International Alliance of Research Universities (IARU), and among Europe’s top-ranking universities, the University of Copenhagen promotes research and teaching of the highest international standard. Rich in tradition and modern in outlook, the University gives students and staff the opportunity to cultivate their talent in an ambitious and informal environment. An effective organisation – with good working conditions and a collaborative work culture – creates the ideal framework for a successful academic career.

Deadline: 15 August 2018
Unit: Det Sundhedsvidenskabelige Fakultet
Campus: Institut for Farmaci
Email: marieke.debruin@sund.ku.dk
Phone:
Read the job description and apply online

Post expires on Wednesday August 15th, 2018