Director, Toxicology, Nonclinical Regulatory Science

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Astellas is announcing a Director, Toxicology, Nonclinical Regulatory Science opportunity at their Astellas Research Institute of America (AIRA) site in Northbrook, IL.

The position has responsibility to directly support Senior Director/Site Manager of Applied Safety (AS) to achieve annual plan of AS. The position also has responsibility for non-clinical safety profiling and characterization of development candidates, implementing non-clinical safety data packages (including plan, execution, outsourcing, and evaluation of toxicity studies), documentations, and regulatory responses, and for enabling regulatory interactions, while reporting to Senior Director/Site Manager, AS, Nonclinical Regulatory Science (NCRS).

• Support Senior Director/Site Manager of AS in managing departmental activities thereby facilitating the timely completion of projects and supporting the professional growth of department members.
• Support Senior Director/Site Manager of AS in managing and overseeing efforts to develop initiatives to improve overall management of NCRS and its integration into related departments.
• Support the Senior Director/Site Manager in the coordination of cooperation with Discovery Accelerators, Product Creation Units, or other partners external to ARO to facilitate access to consultation experts from Applied Safety.
• Execute nonclinical safety program management:
• Preparation of non-clinical safety development plans
• Provision of non-clinical safety information to global PJ teams
• Preparation of non-clinical safety sections of Investigator Brochures, Briefing Documents, INDs and NDAs, and responses to queries from regulatory authorities
• Collaborate closely with other internal stake holders (ex. Research, M&D, PTEC) to make rational decisions to achieve clinical safety and to obtain approvals from the regulatory agencies with speed and quality.
• Supports post-marketing information updates from non-clinical safety perspectives and provide safety data and rationale in post-marketing clinical trials, if necessary
• Oversee/execute assessment of non-clinical safety profile of in-licensing program candidate
• Contribute to promote the development for the PJ in the late stage through planning and execution of toxicity studies with appropriate study designs, while complying the GLP.
• Direct collection and accumulation of safety information from both internal and external sources.
• Utilize CROs and other external research functions for improvement and acceleration in the research area
• Establish communication channels with non-clinical safety personnel from external government regulatory agencies, academia, and industry.
• To provide expertise to these organizations in order to influence the advancement of regulatory science.
• Reports to Senior Director/Site Manager, AS, NCRS