What are the responsibilities and job description for the Senior Toxicology Strategist position at Stratacuity: Proven Scientific Placement?
About the Role
We are seeking an experienced Senior Toxicology Strategist to drive nonclinical safety strategies and oversee scientific studies. This role will be instrumental in ensuring regulatory compliance and authoring critical regulatory documents for clinical development support.
Key Responsibilities
- Develop and execute nonclinical safety programs to support lead selection, candidate nomination, and clinical development.
- Provide scientific leadership and oversight of in vitro and in vivo nonclinical safety studies, including genetic and general toxicology, safety and secondary pharmacology, and developmental, reproductive, and juvenile toxicology testing.
- Maintain up-to-date knowledge of evolving regulatory requirements and ensure nonclinical safety assessment studies comply with US FDA and OECD GLP regulations.
- Author nonclinical safety-relevant portions of regulatory documents, including pre-IND, IND, annual updates, IB, DSUR, PIP/PSP, and briefing booklets for US and ex-US regulatory meetings and filings.
Requirements
- DVM/PhD (highly preferred), DVM, or PhD in toxicology, pharmacology, or a related field.
- 12 years of experience in nonclinical safety assessment in the biotechnology, pharmaceutical, or CRO industries, with at least 5 years in a senior leadership role.
- Deep knowledge of genetic and general toxicology, safety and secondary pharmacology, DART, and related regulatory requirements.
- Proven track record in designing, executing, and managing nonclinical safety programs.
