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 on-line. 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.