Astellas Pharma Director, Toxicology, Nonclinical Regulatory Science in Northbrook, Illinois
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Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
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
Comprehensive knowledge of drug development, especially in nonclinical safety.
Thorough knowledge of FDA/ICH regulations pertaining to nonclinical safety.
Excellent communications skills (active & passive) in own language and in English
Leadership and team management skill.
PhD in toxicology, biochemistry, pharmacology, pharmaceutical or related sciences with 7 years work experience.
Robust human network
Understanding R&D policy / strategy of Astellas
Knowledge or experience of drug development, especially IND and NDA
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Non-clinical Regulatory Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans