Senior Toxicology Scientist - Drug Safety & Regulatory Lead

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

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.