Haeger & Carlsson are recruiting a Clinical Project Associate to join Diamyd Medical a Swedish Biotech company in a strong development phase.
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. DIAGNODE-3, a confirmatory Phase III trial is now on-going. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia.
As Clinical Project Associate you will be part of the R&D department and be responsible for planning, coordination and execution of clinical trials as delegated by the Clinical Program Lead. You will also be involved in various other ongoing activities within R&D such as preclinical development, Chemistry, Manufacturing and Control (CMC) and regulatory activities. For a curious and driven person this is an opportunity to develop skills within Drug development.
You will report to the Chief Operating Officer. The company is located in Stockholm City.
- Planning, coordination and execution of clinical trials
- Support regulatory activities in connection with the clinical trials
- Ensure that all clinical activities are compliant with ICH-GCP, regulatory requirements and company SOPs
- Manage Clinical trial subcontractors and perform sponsor oversight
- Support administrative tasks as needed
- MSc or similar from a scientific or medical program
- Clinical Drug Development (30 hp) or similar course
- Preferably at least 2 years of experience in Clinical trial management
- Good knowledge and understanding of clinical trials and ICH-GCP
- Medical and scientific writing skills
- Experience in monitoring clinical trials is a merit
- Experience from working in a Clinical Research Organization (CRO), Biotechnological research, CMC or with Regulatory activities is meriting
- Highly proficient in spoken and written English and Swedish
Please apply through www.haegercarlsson.com
Questions are answered by Lena Sörskog +46(0)70- 692 45 70, email@example.com