Backed by GV.
About the role
Nimbus has an outstanding opportunity for an exceptional Director / Senior Director of Nonclinical Safety to join our team. This role will lead the safety strategy, through both preclinical and clinical stages, and direct all phases of in vivo GLP and non-GLP toxicology studies, in collaboration with study teams, CROs and consultants. The person in this role will interface with various functional groups within the company and will report to our ED of Nonclinical Safety.
What they're looking for
- Develop the strategic nonclinical toxicology development plan for programs in development in collaboration with stakeholders
- Represent Nonclinical Safety at cross-functional project teams
- Oversee the design and execution of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs consistent with company timelines and goals
- Contribute to the selection and management of consultants and CROs to support nonclinical safety studies for development programs
- Ensures completion of nonclinical safety studies to support Company timelines and goals
- Respond to questions and prepare discussions documents for the FDA to in support of development programs
More about this role
Nimbus has an outstanding opportunity for an exceptional Director / Senior Director of Nonclinical Safety to join our team. This role will lead the safety strategy, through both preclinical and clinical stages, and direct all phases of in vivo GLP and non-GLP toxicology studies, in collaboration with study teams, CROs and consultants. The person in this role will interface with various functional groups within the company and will report to our ED of Nonclinical Safety.
- Develop the strategic nonclinical toxicology development plan for programs in development in collaboration with stakeholders
- Collaborate with CMC, Program & Portfolio Management, Clinical, Medical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND/CTA filing, and clinical development of new small molecule drug entities
- Represent Nonclinical Safety at cross-functional project teams
- Oversee the design and execution of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs consistent with company timelines and goals
- Contribute to the selection and...
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