Senior Scientist – Toxicology

Monte Rosa Therapeutics, Inc; Basel; On-site; CHF 140,000 - 210,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. is seeking a toxicologist to direct nonclinical safety and toxicology work across discovery to development.

The role involves designing and overseeing in silico, in vitro, ex vivo, and in vivo studies, coordinating with CROs, and supporting regulatory submissions such as INDs and NDAs. The candidate will interact with biology, medicinal chemistry, CMC, DMPK, and clinical science teams, driving hit identification, hit-to-lead strategies, and partnership development.

Qualifications

• PhD or DVM with 5+ years in preclinical toxicology.
• Master’s with 10+ years in preclinical toxicology.
• Familiar with GLP, ICH and OECD guidelines; FDA and EMA regulatory requirements.
• Experience working with CROs.
• Strong written and verbal communication skills.

Responsibilities

• Develop toxicology studies for Monte Rosa’s lead programs.
• Collaborate with cross-functional teams to integrate toxicology data into project decisions.
• Design early in vitro toxicity screens and safety pharmacology studies with CROs/academic partners.
• Execute studies to address mechanistic issues and adverse findings in preclinical/clinical contexts.
• Select CROs and oversee as Study Monitor for in vitro/in vivo toxicology studies.
• Design protocols and review amendments.
• Prepare and review toxicology sections for regulatory submissions (INDs, IBs, NDAs).

Skills

Toxicology expertise

Regulatory knowledge

CRO management

Communication skills

Education

PhD or DVM with 5+ years

MSc with 10+ years

Job description

Overview

Monte Rosa Therapeutics is searching for a toxicologist to direct nonclinical safety and toxicology work for programs to enable drug candidates during all phases from discovery through development.

This individual contributor role will contribute to the research and development strategy and will report to the Senior Director of Nonclinical Development, by designing, conducting or overseeing studies, analyzing and interpreting results, ensuring appropriate quality of documentation and record keeping, in close collaboration with other scientists, for a broad range of nonclinical activities:- in silico, in vitro, ex vivo, and in vivo studies;- non-GLP and GLP studies;- nonclinical pharmacology, PK/PD, and toxicology studies, mainly conducted at Contract Research Organizations (CROs).

The toxicologist will also support global regulatory activities related to nonclinical sections of filings including Investigational New Drugs (INDs), annual reports, Investor Brochures (IBs) and New Drug Applications (NDAs), and annual reports. The toxicologist will interact directly with multidisciplinary teams including biology, medicinal chemistry, CMC, DMPK, clinical science, in research and development projects, to move discovery candidates into development. Introduction and growth into regulatory toxicology will be an extension of this position. The ideal candidate will be able to help evolve Monte Rosa’s hit identification and hit-to-lead endeavors through embracing novel assay technologies, enhancing overall process and actively drive internal and external partnerships.

Responsibilities

• Develop toxicology studies for Molecular Glue Degraders by bridging Monte Rosa’s platform to aid in the understanding and derisking of potential issues.
• Work cross functionally and culturally with departments on in vitro and in vivo models, weaving in toxicological datapoints to help mitigate findings.
• 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 CROs and/or academic collaborators.
• 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.
• Select CROs and represent Monte Rosa as the Study Monitor for various in vitro and in vivo toxicology studies.
• Responsible for protocol design and reviewing protocol amendments.
• 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 INDs, IBs and NDAs.

Qualifications

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