Summary / purpose of the position
For his/her projects,
- Accountable for the scientific and operational support to the non-clinical safety studies (safety pharmacology and toxicology) to be performed on any development program from research to post-marketing approval
- Accountable for nonclinical safety input within project/asset team, governance bodies and support to integrated development plan
- Actively Participation to the integration of data from other disciplines and evaluation of the impact on safety
- Responsible for derisking strategy and consequences for the project and communicate to the project/Asset team
Main responsibilities / job expectations
- Responsible for the optimization of nonclinical development plans of products: identifying toxicology pre-requests, proposing toxicology development plan, communicating with all other functional areas involved in project
- Contribute to project/asset team brainstorm for the delivery of optimized development plans
- Responsible for non-clinical drug safety part of lB, CIA, IMPD, IND, Briefing documents, Expert reports
- Contribute to non-clinical module for submissions
- Contribute to the preparation of the nonclinical documentation and the representation of the nonclinical function for EU & US agency consultations
- Contribute to identification of external experts to solve an issue/unexpected finding and restitution of the conclusions and recommendations
- Master a discipline within preclinical safety and serve as expert to project teams for issue resolution and derisking strategies in this field
- Serve as a safety expert on “In or Out-Licensing” activities
EHS responsibilities:
- Comply with applicable EHS regulations and procedures
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
Knowledge, abilities & experience
Education / Certifications:
Doctorate level in Toxicology plus DVM or Pharm D or MD or PhD. Board certification (ABT or ACVP) is a plus
Experience:
- 10 years in pharmaceutical industry
Languages:
- English and French
Key Technical Competencies Required
- General scientific knowledge of the toxicology science (genotoxicity, reproductive toxicology, general toxicology, investigational toxicology)
- Transversal thinking and awareness for an asset, i.e. understanding of the multiple factors playing a direct or indirect role in the research and development of molecules as well as on regular regulatory review and approval of the submitted information
- Complementary expertise in a specific domains of toxicology
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