PhD fellowship in Regulatory Science

Københavns Universitet (KU)

Ph.d. & forskning
Storkøbenhavn

Department of Pharmacy

Faculty of Health and Medical Sciences (SUND)
University of Copenhagen

The Section of Social and Clinical Pharmacy (SCP) in collaboration with the Copenhagen Centre for Regulatory Sciences (CORS), Department of Pharmacy is offering a three-year PhD fellowship in Regulatory Science. The PhD fellow will further collaborate with the Section of Biologics at the Department of Pharmacy and Centre for Information and Innovation Law (CIIR). The fellowship is financed by LEO Pharma. The fellowship is available from 1 October 2017 or as soon as possible after this date.

The Section of Social and Clinical Pharmacy performs research in social and clinical pharmacy. Social pharmacy seeks to have the broad view of medicines in society and focuses on how medicines are perceived, used, and managed by different actors in society. Clinical pharmacy seeks to ensure the optimal and rational use of medicines for the benefit of patients and society through collaboration between pharmacists, other health professionals, and the patient. CORS focuses on research within Regulatory Science which is defined as "The science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision making". The Section for Biologics focuses on advanced formulation design and characterization of delivery systems. This is a prerequisite for converting biological molecules into medicines. The objective of the CIIR is to establish a research body dealing with the legal issues within the information and innovation law areas such as copyright, trademarks, patents, trade secrets, data protection and personality rights.

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

Project description
In the past decade, a significant number of biosimilar medicinal products have reached the market, primarily in the European Union. Biosimilars can be considered generic forms of innovator biological medicinal products, where the term “similar” is used to acknowledge the inability to make an exact copy of the reference product. However, very little is known how the term “similar” is understood by various stakeholders and how this impacts market penetration and use of biosimilars. It is therefore important to increase the understanding of the decision-making process of regulatory assessors and pharmaceutical industry regarding biosimilars. Secondly, it is important to map the views on and understanding of biosimilars by prescribers and patients, and how these may affect the use of biosimilars in daily clinical practice.

The PhD fellow will explore the views of stakeholders in Europe (assessors, industry, clinicians, and users) on “similarity”. This work enters a novel field of enquiry and is of large clinical and economic significance.It can contribute to an improved and more transparent evaluation, improved education, and improved dialogue about marketing and use of biosimilars in society.

The fellow will work closely with social pharmacy researchers, regulatory science, legal experts, and researchers in biologics to undertake this project. The position will be ideally suited to a person who is interested in pursuing a career in research or a high-level career within regulatory affairs. The position provides an opportunity to develop expertise in qualitative social science methodology and theory.

Principal supervisor
Professor Anna Birna Almarsdóttir, Department of Pharmacy, University of Copenhagen

E-mail: , direct phone: +45 3533 3715

Required qualifications
As an applicant you must have:

  • Master’s degree or equivalent in a relevant field to the proposed work (pharmacy, law, political science, medicine, or other relevant fields).
  • An interest in cross-disciplinary work across social sciences and pharmaceutical technology.
  • Ability and enthusiasm to learn new methods and theories within the social sciences and a genuine interest in regulatory science.
  • Good communication skills in English, both oral and written.

Preferred qualifications

  • Overall a preferred applicant has an excellent academic track record and is highly motivated to study issues within the pharmaceutical arena.
  • 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.
  • Good communication skills in another European language than English, both oral and written.

Job description

  • Your 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 of applicants

  • 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 be requested to formally apply for enrolment as a PhD student at the Faculty of Health and Medical Sciences subject to the rules stipulated in the Ministerial order on the PhD programme at the universities (PhD order) from the Ministry of Science, Innovation, and Higher Education and the guidelines for the PhD programme at the Faculty of Health andMedical Sciences.

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

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

Salary, terms and conditions of appointment are set in accordance with the Agreement between the Ministry of Finance and AC (Danish Confederation of Professional Associations) or other relevant professional organizations. The position is covered by the Protocol on Job Structure.

Minimum monthly salary is DKK 26,073 (taxable) + pension contribution.

Workplace is located at PharmaSchool, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.

Application procedure
The application, in English, 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

The University of Copenhagen wishes to encourage everyone interested in this post to apply, regardless of personal background.

Deadline for applications
Monday 24 July 2017. Applications received later than this date will not be considered.

Please note that only online applications will be accepted.

Post application procedure
After the expiry of the deadline, the authorized recruitment manager selects applicants for assessment on the advice of the Appointments Committee.

All applicants are then immediately notified whether their application has been passed for assessment by an expert assessment committee.

Selected applicants are notified of the Appointment Committee composition and each applicant has the opportunity to comment on the part of the assessment that relates to the applicant him/herself. You can read about the recruitment process at http://employment.ku.dk/.

The Appointments Committee consists of the supervision group and the Head of Department who is the authorized recruitment manager. The Expert Assessment Committee consists of the principal supervisor.

Interviews will be held with potential candidates on August 17, 2017. An answer to the granting of the fellowship can be expected approx. 1 week after the interview.

Questions
For further information, applicants may contact the supervisor or Administrator Marianne W. Jørgensen, e-mail: , direct phone: +45 3533 6449.

You can read more about the Copenhagen Center for Regulatory Science at http://pharmacy.ku.dk/research/cors/

You can read more about the Section of Social and Clinical Pharmacy at http://pharmacy.ku.dk/research/social_clinical_pharmacy/

You can read more about the Section for Biologics at http://pharmacy.ku.dk/research/biologics/

You can read more about the Center for Information and Innovation Law at http://jura.ku.dk/ciir

For information on working and living in Denmark visit http://ism.ku.dk/ (International staff mobility) and www.workindenmark.dk


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Opslag oprettet d. 16.06.2017, sidst opdateret d. 16.06.2017




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