Director / Associate Director – Toxicology

Responsibilities:
- Direct and develop nonclinical toxicology strategies across discovery through development; contribute to R&D strategy.
- Design, conduct, and/or oversee in vitro, ex vivo, and in vivo non-GLP (or GLP at CROs) nonclinical pharmacology, PK/PD, and/or toxicology studies; ensure quality documentation and recordkeeping.
- Develop toxicology studies for Molecular Glue Degraders to understand/minimize potential issues.
- Collaborate cross-functionally on in vitro and in vivo models, incorporating toxicology datapoints to mitigate findings.
- Plan early toxicity screening and/or secondary safety pharmacology studies for small molecules; implement and manage studies with CROs and/or academic collaborators.
- Execute studies to address mechanistic issues or unpredicted adverse findings in preclinical and/or clinical trials; deliver results timely.
- Select CROs and serve as Study Monitor for toxicology studies.
- Lead protocol design and review protocol amendments.
- Review experimental data; deliver toxicology reports for regulatory submissions; support preparation of safety pharmacology/toxicology sections for INDs, annual reports, Investor Brochures (IBs), and NDAs.

Qualifications:
- PhD (or DVM) and 5+ years experience, OR Master’s degree and 10+ years experience in preclinical toxicology/drug development (pharma/biotech); DABT preferred.
- Knowledge of GLP regulations and ICH/FDA guidelines.
- Experience working with Contract Research Organizations.

Skills:
- Strong written and verbal communication.
- Ability to deliver clear presentations to internal and external audiences.

Application Instructions:
- Submit resume and cover letter to careers-US@monterosatx.com, or apply online at www.monterosatx.com.