Clinical development scientist
We seek a clinical development scientist to join our new team in Human Health Clinical Development located in Hoersholm, Denmark.
Chr. Hansen is a world leading company which develops and manufactures microbial culture and enzyme-based products for the food as well as health & nutrition industries. Human Health (HH) Clinical Development is part of our HH Business unit, the fastest growing area in Chr. Hansen. HH delivers high quality probiotics to the global market within gastrointestinal and vaginal healthcare. HH Clinical Development is responsible for the delivery of clinical data for our project portfolio of dietary supplements with health claims.
Your main task is to provide clinical research expertise and medical supervision to the objectives of the Clinical Development Plan (CDP) and to the design, conduct and reporting of clinical trials. This will also entail that you:
- Identify the medical and clinical development implications of pre-clinical findings and any other findings preceding the start of the first-in-human clinical study
- Contribute to the definition of the Target Product Profile (TPP)
- Ensure alignment of clinical study protocols with clinical practices, state of the art development methodologies and regulations in order to produce scientifically sound and conclusive results
- Collaborate with/point of contact to clinical research organizations
- Prepare/compile and contribute to scientific documents (e.g., Investigator’s Brochure, regulatory/safety reports, Risk Management Plans) and ensure their medical accuracy
- Ensure alignment of non-clinical program, clinical study protocols, clinical study reports and publications with CDP and TPP within specific programs
- Act as clinical development reference for innovation in probiotics and therapeutic bacteria
Your personal profile
We expect you to be a highly motivated and ambitious scientist with the following qualifications:
- You hold a Ph.D. in life sciences, with a clinical science focus
- 4-8 years (or more) of experience in clinical development (especially phase 1 and 2) in pharma or food ingredients
- Demonstrated ability to independently envision, plan and implement a research project
- Knowledge of the European and US regulatory frameworks for food and medicinal products is an advantage
- A significant amount of entrepreneurship and a solid sense of solving problems
A very challenging and exciting position in a global company - one of the largest players within development and production of probiotics. You will have excellent opportunities for personal development as well as for forming the team to meet the future. We offer a great working environment, where you get the opportunity to influence you own work, and follow the impact of this.
If you have any questions related to the position, please feel free to contact Anders B. Damholt, Head of HH Clinical Development at +45 5218 0174.
Please apply online by "Apply here". We will call for interviews as we receive qualified applications.
Deadline for applications is no later than 28 October 2016.
Read more about working for Chr. Hansen at www.chr-hansen.com/career.
Chr. Hansen is a global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. Products include cultures, enzymes, probiotics and natural colors, and all solutions are based on strong research and development competencies coupled with significant technology investments. Revenue in the 2012/13 financial year was EUR 738 million. The Company holds a leading market position in all its divisions: Cultures & Enzymes, Health & Nutrition and Natural Colors. It has more than 2,500 dedicated employees in 30 countries and main production facilities in Denmark, France, the US and Germany. Chr. Hansen was founded in 1874 and is listed on NASDAQ OMX Copenhagen.