Senior Scientist - Non-Clinical Development
An amazing job opportunity has arisen in Amsterdam for a Senior Scientist to work in Non-Clinical Development. This is the perfect chance to bring your experience and expertise to a leading biopharmaceutical organisation.
- Preparation of strategic non-clinical program development plans
- Representing non-clinical in global multidisciplinary project teams
- Designing, planning, monitoring and reporting non-clinical safety studies in accordance with the development plans.
- Writing of scientific expert documents for regulatory submissions in support of clinical development studies and market authorization approval.
- Develop and evaluate new methods and models (e.g. animal models) to support non-clinical development.
- Staying up to date about the scientific trends and developments within the non-clinical area and incorporate into the non-clinical programs.
Skills and Requirements
- Holds a MSc or PhD (toxicology / biochemistry/ pharmacology) and/or comparable level of training by experience.
- Possesses minimum 3 years' experience with the conduct of non-clinical animal studies in an industrial setting, preferably pharmaceutical industry.
- Expertise in the field of gene therapy, immunology and/or DNA integration is advantageous.
- Registration as Acknowledged Toxicologist is beneficial.
- Strong knowledge of regulatory policies and guidance documents on non-clinical
- pharmaceutical studies
- Significant experience with writing regulatory documentation and regulatory interactions.
- Hands-on experience with animal studies and handling of samples derived from such studies.
- Experience with method development and in vivo (disease) model qualification/validation
- Experience with Good Laboratory Practice or other quality management systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.