Non-clinical Drug Safety Project Manager

il y a 2 jours

Paris, France Ipsen Innovation (SAS) Temps plein

**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

**#LI-Hybrid**

LI-MC1

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