Director / Associate Director – Toxicology
Monte Rosa Therapeutics
4 hours ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Lead and develop nonclinical toxicology strategies to support drug candidates across all phases of development.
- Design, conduct, and/or oversee in vitro, ex vivo, and in vivo non-GLP (or GLP studies conducted at CROs) nonclinical pharmacology, PK/PD, and/or toxicology studies.
- Ensure appropriate quality of documentation and record keeping.
- Support global regulatory activities for nonclinical sections of filings, including INDs, investor brochures (IBs), and annual reports.
- Collaborate with multidisciplinary internal teams (biology, medicinal chemistry, DMPK, clinical science) and external CROs to advance candidates from discovery into development.
- Develop toxicology studies for Molecular Glue Degraders to understand/minimize potential issues.
- Work cross-functionally on in vitro and in vivo models, integrating toxicology data to mitigate findings.
- Design early in vitro toxicity screening and/or secondary/safety pharmacology studies; implement and manage studies with CROs and/or academic collaborators.
- Execute studies addressing mechanistic issues and/or unpredicted adverse findings in preclinical/clinical settings; deliver results on a timely basis.
- Select CROs and serve as Study Monitor for toxicology studies.
- Perform protocol design and review protocol amendments.
- Review experimental data; ensure timely toxicology report delivery for regulatory submissions; assist with safety pharmacology and toxicology sections for INDs, annual reports, IBs, and NDAs.
Qualifications:
- PhD degree or DVM with 5+ years of scientific experience, or Master’s degree with 10+ years of scientific experience in preclinical toxicology and drug development (pharmaceutical/biotechnology); DABT preferred.
Skills/Requirements:
- Familiarity with GLP regulations and ICH/FDA guidelines for toxicology studies supporting regulatory filings.
- Experience working with Contract Research Organizations.
- Ability to develop and deliver clear, concise presentations for internal and external meetings.
- Outstanding written and verbal communication skills.
- Lead and develop nonclinical toxicology strategies to support drug candidates across all phases of development.
- Design, conduct, and/or oversee in vitro, ex vivo, and in vivo non-GLP (or GLP studies conducted at CROs) nonclinical pharmacology, PK/PD, and/or toxicology studies.
- Ensure appropriate quality of documentation and record keeping.
- Support global regulatory activities for nonclinical sections of filings, including INDs, investor brochures (IBs), and annual reports.
- Collaborate with multidisciplinary internal teams (biology, medicinal chemistry, DMPK, clinical science) and external CROs to advance candidates from discovery into development.
- Develop toxicology studies for Molecular Glue Degraders to understand/minimize potential issues.
- Work cross-functionally on in vitro and in vivo models, integrating toxicology data to mitigate findings.
- Design early in vitro toxicity screening and/or secondary/safety pharmacology studies; implement and manage studies with CROs and/or academic collaborators.
- Execute studies addressing mechanistic issues and/or unpredicted adverse findings in preclinical/clinical settings; deliver results on a timely basis.
- Select CROs and serve as Study Monitor for toxicology studies.
- Perform protocol design and review protocol amendments.
- Review experimental data; ensure timely toxicology report delivery for regulatory submissions; assist with safety pharmacology and toxicology sections for INDs, annual reports, IBs, and NDAs.
Qualifications:
- PhD degree or DVM with 5+ years of scientific experience, or Master’s degree with 10+ years of scientific experience in preclinical toxicology and drug development (pharmaceutical/biotechnology); DABT preferred.
Skills/Requirements:
- Familiarity with GLP regulations and ICH/FDA guidelines for toxicology studies supporting regulatory filings.
- Experience working with Contract Research Organizations.
- Ability to develop and deliver clear, concise presentations for internal and external meetings.
- Outstanding written and verbal communication skills.