Section Manager for Clinical and Non-Clinical Development

Statens Serum Institut

Fuldtidsjob
Storkøbenhavn

Center for Vaccine Research (CVR) is housing a world-leading vaccine research and clinical program directed against some of the major global infectious diseases (Tuberculosis and Chlamydia) and cancer. The center focuses on research and development of next-generation vaccines and diagnostic tools. We can efficiently move products from research into clinical trials. Currently, CVR’s activities in clinical trials are increasing within both Tuberculosis and Chlamydia vaccines, as well as novel approaches in cancer immunotherapy using novel adjuvant systems. We collaborate closely with a large number of institutions and are externally funded by e.g. the European Commission and National Institutes of Health.

Clinical and Non-Clinical development in the vaccine development department
CVR focuses on vaccine research within infectious immunology and has a unique composition of basic, translational vaccine research combined with GMP facilities, animal model test facilities enabling accelerated exploitation of research results into development of new vaccines. The vaccine development department is a “one stop shop” where projects are organized in a matrix organization and the department sections are involved from cloning to clinical data.

Section for Clinical and Non-Clinical development (CLINC) works with clinical development of new vaccines. The group is responsible for planning, outsourcing, performing, oversight and reporting of clinical trials in accordance with ICH GCP and for outsourcing, planning and oversight of GLP toxicology studies. As our new Section Manager you will lead a team of six consisting of clinical trial managers, medical writers, a toxicology study manager and a safety manager.

Responsibilities
Your primary tasks will be:

  • Daily management of the clinical and non-clinical section including resource allocation
  • Point of contact for collaborators, partners, funding bodies etc regarding clinical development
  • Responsible for overall design, planning, conduct, reporting and budgeting of clinical trials and non-clinical toxicology studies
  • Responsible for selection and oversight of CROs for clinical trial activities including pharmacovigilance and non-clinical toxicology studies
  • Contract negotiation with CROs and external collaborators
  • Securing compliance to the current pharmacovigilance, GLP and ICH GCP guidelines
  • Securing oversight of clinical trial activities and non-clinical toxicology study activities.

Required qualifications:
We are looking for candidates who have:

  • Relevant scientific education combined with a minimum of five years of working experience, preferably within clinical development
  • Extensive GCP experience
  • Experience with clinical trial design, planning, conduct and reporting
  • Experience with budget management
  • Knowledge of immunology and vaccines is an advantage
  • Fluency in English and Danish both orally and in writing
  • Management experience is an advantage
  • Personal qualifications

We expect you to have excellent communication and interpersonal skills. You are dedicated team player who are motivate by creating results through others. Furthermore you are structured with good overview. Most importantly you are ambitious on behalf of yourself and your team, have a positive mindset and take interest in your colleagues.

We offer
We offer a job in an exciting international research environment with good possibilities for personal and scientific development and meaningful work in a dynamic, hectic and inspiring work environment

We are a flexible and family-oriented workplace with 37 hour work week including lunch break. We have our own sports club offering a wide range of activities. Our offices are placed centrally in Copenhagen, close to public transport.

Terms of employment
Salary and appointment terms will be based on the collective agreement between the Danish Ministry of Finance and the Danish Federation of Professional Associations (AC) (overenskomst for akademikere i staten).

Further information
For further information please contact Director Vaccine Development Ingrid Kromann at +45 3268 8252 / +45 2224 3873.

Are you interested?
Click on "søg stillingen" and send us your application and CV including documentation of education. Interviews are expected to be held in weeks 6-8.


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Ansøgningsfrist d. 08.06.2020
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