The Swiss Biotech Association is seeking a Senior Director of Toxicology in Basel to lead nonclinical safety strategies and oversee toxicology studies for drug candidates from discovery through development.
This individual contributor position reports to the Senior Director of Nonclinical Development. The role focuses on directing nonclinical safety and toxicology work to support diverse drug candidates throughout all development phases. The position also contributes to the broader R&D strategy.
Responsibilities
- Design and manage toxicology studies for Molecular Glue Degraders, connecting Monte Rosa’s platform to identify and reduce potential risks.
- Collaborate across departments to integrate toxicological data into in vitro and in vivo models, helping to address and mitigate findings.
- Help design early in vitro toxicity screening and safety pharmacology studies for small molecules at various preclinical stages.
- Oversee study execution with Contract Research Organizations (CROs) and academic partners.
- Conduct studies to resolve mechanistic questions or unexpected adverse events in preclinical and clinical trials, delivering results promptly to project and leadership teams.
- Select CROs and act as the Study Monitor for various in vitro and in vivo toxicology studies.
- Design protocols and review any amendments.
- Analyze experimental data and ensure timely delivery of toxicology reports for regulatory submissions.
- Support the preparation of safety pharmacology and toxicology sections for Investigational New Drug (IND) applications, annual reports, Investor Brochures (IBs), and New Drug Applications (NDAs).
Requirements
- PhD or DVM with at least 5 years of scientific experience, or a Master’s degree with 10 years of experience in preclinical toxicology and drug development within the pharmaceutical or biotechnology industry.
- Knowledge of GLP regulations and ICH/FDA guidelines for conducting toxicology studies to support regulatory filings.
- Experience working with Contract Research Organizations.
- Ability to create and deliver clear and concise presentations for internal and external meetings.
- Excellent written and verbal communication skills.
Nice to have
- DABT certification is preferred.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.