Director / Associate Director – Toxicology

Monte Rosa Therapeutics seeks a Senior Director or Associate Director of Toxicology in Basel to lead nonclinical safety strategies for drug candidates from discovery through development.

This individual contributor position reports to the Senior Director of Nonclinical Development. The role is responsible for directing nonclinical safety and toxicology work across programs, enabling drug candidates to progress from discovery into development phases. The incumbent leads the creation and execution of toxicology strategies that support diverse drug candidates throughout their lifecycle.

Responsibilities

• Design and oversee toxicology studies for Molecular Glue Degraders, leveraging Monte Rosa’s platform to identify and mitigate potential risks.
• Collaborate cross-functionally to integrate toxicological data into in vitro and in vivo models, helping to address and minimize experimental findings.
• Contribute to the design of early-stage in vitro toxicity screening and safety pharmacology studies for small molecules during preclinical research.
• Manage and execute studies in partnership with Contract Research Organizations (CROs) and academic collaborators.
• Conduct studies to resolve mechanistic questions or unexpected adverse events observed in preclinical or clinical trials, ensuring timely result delivery.
• Select CROs and serve as the Study Monitor for various in vitro and in vivo toxicology assessments.
• Develop study protocols and review any necessary amendments.
• Analyze experimental data and ensure the prompt delivery of toxicology reports suitable for regulatory submissions.
• Support the preparation of safety pharmacology and toxicology sections for Investigational New Drug (IND) applications, annual reports, Investor Brochures, and New Drug Applications (NDAs).

Requirements

• A PhD degree with at least five years of scientific experience, or a Master’s degree with ten years of experience, specifically in preclinical toxicology and drug development within the pharmaceutical or biotechnology industry.
• Working knowledge of GLP regulations and ICH/FDA guidelines for conducting toxicology studies to support regulatory filings.
• Proven experience collaborating with Contract Research Organizations.
• Strong ability to create and present clear, concise materials for internal and external audiences.
• Excellent written and verbal communication capabilities.

Nice to have

• DABT certification.

About the company

Monte Rosa Therapeutics focuses on evolving hit identification and hit-to-lead processes by adopting novel assay technologies. The company emphasizes enhancing overall operational processes and actively driving both internal and external partnerships to advance its scientific goals.

• Embracing novel assay technologies to improve hit identification and hit-to-lead endeavors.
• Actively driving internal and external partnerships to enhance scientific processes.