- Domaine d'activité
- Recherche & Développement
- Human care
- Marcq-en-Barœul, France
- Type de contrat
- Permanent Contract
- 1 to 3 years
Description de l'offre
In this context, Gnosis by Lesaffre is recruiting a Clinical Study Manager to join its Research and Application department. You will be part of the Substantiation & Applications Team and report to the Substantiation Plan Manager.
Within the Research and Application department, the Substantiation & Applications team is responsible for the assessment and substantiation of the efficacy and safety of every ingredient of the commercial range and innovation pipeline of Gnosis by Lesaffre. Our portfolio includes usable nutritional actives, probiotics and prebiotics, and nutritional/functional yeasts obtained by biotransformation and that benefit human wellbeing. The team is also highly involved in the valorisation of the scientific results through oral and written communications.
The Substantiation & Applications team is working very closely with the Market Managers and Key Account Managers, providing support to develop promotional materials and answer customers’ requests. An equivalent support is brought to Regulatory Affairs Specialists to complete market access and claims dossiers. Finally, collaborators of the team are project managers, thus coordinating every aspect of the development of new products as well as multidisciplinary project teams.
Within Gnosis by Lesaffre, the Clinical Study Manager is in charge of:
STUDY MANAGEMENT: design, set-up, coordinate, monitor and promote non-clinical & clinical studies
PROJECT MANAGEMENT: responsible for a whole project or a project technical workpackage
SCIENTIFIC WRITING: literature search, selection, review and synthesis of relevant publications.
MARKET PROMOTION OF SUBSTANTIATION: support marketing and sales in the commercial promotion of substantiation (trainings, development of marketing messages and sales materials, participation in key meetings with customers, etc.).
SCIENTIFIC SUPPORT: provide scientific support in answering substantiation-related customers’ request, in benchmarking the substantiation of competitors’ ingredients, in developping new ideas, in filling market access or health claim dossiers.
SCIENTIFIC COMPETITIVE INTELLIGENCE: Monitor scientific publications on ingredients & applications of interest.
Life sciences engineering degree or master’s degree with human health specialization, Pharma or PhD degree.
1 to 3 year’s experience in:
- Expertise in clinical studies management from conception to promotion
- Scientific writing
- Literature review, analysis and synthesis
- Project management
- Preclinical & clinical study methodologies
- Life sciences, nutrition and probiotic, nutritional actives
- Project management
- Clinical study designs, set up, monitoring and promotion
- Ability to analyze and summarize information (Literature review and synthesis)
- Scientific writing and oral presentations (English)
- Rigor & serious
- Team spirit & cooperative
- Good communication skills
Description de l'entreprise
For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre.
At Gnosis by Lesaffre, we are committed to cultivating and to delivering nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing, thanks to the power of microorganisms and biotransformation processes like fermentation. Put differently, we explore life to improve living.
Our vision: At Gnosis by Lesaffre, we strive for a world that moves better, digests better, ages better, feels better, and, ultimately, lives better thanks to microorganisms and biotransformation.