Regulatory and clinical trials expert within oncology
Karolinska Institutet, Department of Medical Biochemistry and Bi / Apotekarjobb / Stockholm
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hela Sverige We are looking for a highly motivated regulatory and clinical trials expert within the oncology field to take strategic responsibility and the lead of the MTH1 clinical programme in the Helleday Laboratory at the Division of Translational Medicine and Chemical Biology.
Karolinska Institutet is one of the leading medical universities in Europe. Through research and education, Karolinska Institutet contributes to improving human health. Our vision, within the Helleday Laboratory, is to translate the findings from our basic research programmes on DNA repair and survival mechanisms within cancer cells, into identification of novel anti-cancer targets and development of anti-cancer drugs with minimal side-effects. Today we have taken discovery projects into pre-clinical phase and are presently planning for initiating clinical trials during next year.
Duties:
The successful applicant will be first to lead an exciting academic drug discovery programme of huge potential, the MTH1 programme, from pre-clinical discovery through clinical phase I and II trials with the ambition to reach FDA/EMA approval. The candidate is expected to work proactively and independently as well as in an interdisciplinary team with a mix of academic and industry competences, to coordinate and set up strategies for clinical studies in accordance with Medical Agency guidelines. As regulatory and clinical trials expert you are expected to plan clinical studies together with national and international clinical collaborators, for academic IST, assist in writing IND application(s) and take an overall responsibility in strategic planning of the clinical development of each project based on your extensive regulatory expertise. You are also expected to guide the pre-clinical development phase on necessary studies to be performed prior to clinical oncology studies.
Entry requirements
The candidate should have a well-documented previous experience within the medical regulatory field as well as clinical trials. A MSc in Pharmacy or medical education is preferred. Experience from drug discovery (development phase) in Pharma company or Medical Agency is a requirement. The successful candidate needs to be well organized, have previous experience of drug development within the oncology research field, experience in documenting research and have a strong passion for developing novel treatments. The work will be performed in multidisciplinary and multicultural project teams and in close collaboration with other academic research groups and clinicians in Sweden and internationally. Therefore, the ability to communicate in English (both oral and written) is highly desirable. The successful candidate should also be able to adopt the innovative and entrepreneurial spirit existing in the group.
Application process
The application is to be submitted on the MyNetwork system and must contain the following documents in Swedish or English:
• A personal letter
• A complete curriculum vitae, including education and training, academic title, previous professional positions, current position, academic distinctions, and committee work.
• A complete list of publications
Information about the position can be obtained from Ulrika Berglund (
ulrika.berglund@ki.se ) or Thomas Helleday (
Thomas.helleday@ki.se ).
At Karolinska Institutet a 6-month trial period is required for all permanent appointments.
Karolinska Institutet är ett av världens ledande medicinska universitet. I Sverige står Karolinska Institutet för drygt 40 procent av den medicinska akademiska forskningen och har det största utbudet av medicinska utbildningar. Sedan 1901 utser Nobelförsamlingen vid Karolinska Institutet mottagare av Nobelpriset i fysiologi eller medicin.
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Varaktighet, arbetstid
100 % tillsvidareanställning
Publiceringsdatum2015-10-07ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2015-10-31
Ange följande referens när du ansöker: 2-3538/2015
Klicka på denna länk för att göra din ansökanKontaktThomas Helleday +46 (0)8-524 800 00
Ulrika Berglund +46 (0)8-524 800 00
Facklig kontaktAnne Edgren, OFR +46 (0)8-616 16 29
Biborka Bereczky Veress, SACO +46 (0)70-173 85 75
Gunnar Stenberg, SEKO +46 (0)8-524 880 75
FöretagKarolinska Institutet, Department of Medical Biochemistry and Biophysics
AdressKarolinska Institutet, Department of Medical Biochemistry and Biophysics
Karolinska Institutet
17177 Stockholm
KontorsadressKarolinska Institutet
Jobbnummer 2467822
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