Senior Scientist Non Clinical Development

Seuss+

The Senior Scientist will be responsible for the overall non-clinical strategy programs for the company's products.

  • Biotechnology
  • Senior Scientist
  • Non Clinical Development
Senior Scientist Non-Clinical Development

Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
 
Purpose of the role
The Senior Scientist will be responsible for the overall non-clinical strategy programs for the company’s products. These programs are crucial for evaluating the risk-to-benefit ratio of the products, also with respect to environmental safety. The Scientist will report to the Head Non-Clinical Development.
 
Place in the Organization
Non-Clinical Development is instrumental in assuring the safety and efficacy of our AAV-based products, guiding the development of our products towards clinical use and marketing authorisation. Non-Clinical Development belongs to the Development organization.
 
Key result areas (major duties, accountabilities, and responsibilities) 
  • Preparation of strategic non-clinical program development plans
  • Representing non-clinical in global multidisciplinary project teams (planning, progress, budget, cross-functional discussion/decision making)
  • 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.
  • Assurance of appropriate quality and robustness of data.
  • Staying up to date about the scientific trends and developments within the non-clinical area and incorporate into the non-clinical programs.
Qualifications & Skills
  • 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 (ICH; OECD: EMA; FDA).
  • 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.
Core competencies
  • Outstanding planning and organizational capabilities to plan own workload and oversee study multisite organization
  • Proactive attitude with high level of ownership and accountability
  • Team player with strong interpersonal effectiveness and collaboration skills to remotely orchestrate study organization.
  • Strong analytical skills, recognizing and signalling important information relevant for safety and efficacy assessment.
  • Clear communication and presentation skills in project teams and beyond
  • Flexible to act in a highly dynamic and demanding environment
Please contact Ian Wood, Senior Recruitment Consultant.
i.wood@consultseuss.com
+31 (0)6 26 65 71 71