Director, Toxicology

Vor 6 Tagen

Schweiz Monte Rosa Therapeutics AG Vollzeit

Director, Toxicology

Location: Basel

Principal

**Responsibilities**:
1. Develop Toxicology studies for Molecular Glue Degraders by bridging Monte Rosa’s platform to aid in the understanding/minimizing of potential issue

2. Work cross functionally and culturally with departments on in vitro and in vivo models, weaving in toxicological datapoints to help mitigate findings

3. Participate in the design of early in vitro toxicity screening and/or secondary/safety pharmacology studies for small molecules in various stages of preclinical research and development. Implement and manage studies with CRO and/or academic collaborators.

4. Execute studies designed to address mechanistic issues and/or unpredicted adverse findings in preclinical and/or clinical trials and provide results on a timely basis to support the ongoing project teams and leadership team.

5. Select CROs and represent Monte Rosa as the Study Monitor for various in vitro and in vivo toxicology studies.

6. Responsible for protocol design and reviewing protocol amendments.

7. Review all experimental data and ensure timely delivery of toxicology reports that may be used for regulatory submissions, and assist in the preparation of safety pharmacology and toxicology sections for Investigational New Drugs (INDs), annual reports, Investor Brochures (IBs) and New Drug Applications (NDAs).

**Requirements**:
PhD degree or DVM & 5 yrs of scientific experience OR Master’s degree & 10 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector; DABT preferred
Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
Experience working with Contract Research Organizations
Ability to develop and deliver clear and concise presentations for both internal and external meetings
Outstanding written and verbal communication skills

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