Non-Clinical Drug Safety Senior Project Manager H/F

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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