住所
仕事の形態【募集の背景 / Purpose & Scope】
This position has responsibility for non-clinical safety profiling and characterization of development candidates (including plan, execution, outsourcing, and evaluation of toxicity studies), documentations, and regulatory interactions to achieve IND/NDA.
This position also could have opportunity to work as an expert in genotoxicity/ immunotoxicity/ reproductive and developmental toxicity/ histopathology etc. considering your own expertise.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
- Work as a program toxicologist in a team which consist of a chemist, pharmacologist, ADME scientist, medical doctor and CMC scientist etc to promote a drug candidate development
- Plan the IND/NDA enabling toxicity and safety pharmacology study-package
- Design toxicity studies and safety pharmacology study with supports from internal experts in genotox, safety pharmacology, immunotox, DART etc.
- Manage toxicity studies conducted in CROs as a study-monitor
- Prepare the toxicological parts of Common Technical Document (CTD) and Investigator's Brochure (IB)
- Prepare responses to queries from regulatory authorities
- In addition to the above, you also could have opportunity to work as an expert in genotoxicity/ immunotoxicity/ reproductive and developmental toxicity/ histopathology etc. considering your own expertise.
（変更の範囲）
会社内での全ての業務
【応募要件 / Qualifications】
＜必須 / Must＞
- Master's Degree in toxicology, pharmacology, or related sciences with 5+ years work experience - Knowledge of drug development, especially in nonclinical safety - Knowledge of regulatory guidance pertaining to nonclinical safety - Excellent communications skills (active & passive) in own language and in English
＜歓迎 / Want＞
- PhD in toxicology, pharmacology or related sciences with 5+ years work experience - Knowledge or experience of drug development, especially IND and NDA - Work experience as an expert in one of the following: genotoxicity, immunotoxicity, reproductive and developmental toxicity, histopathology etc.
【応募書類 / Application Documents】
和文履歴書（必須）・和文職務経歴書（必須）・英文レジュメ（任意）
Resumes
【選考プロセス / Selection details】
書類選考 → 1次面接 → 適性検査 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Aptitude test → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
茨城県つくば市 アステラス製薬 つくば研究センター
Tsukuba, Ibaraki
※ＪＲひたち野うしく駅とつくばエクスプレス（TX) 研究学園駅より通勤バスがございます。
（変更の範囲）
会社内での全ての業務
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
①基本給：当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:30～17:30（月～木）、8:30～15:45（金）、専門業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす。
8:30～17:30（Mon～Thu）、8:30～15:45（Fri）
Discretionary Work System
【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."
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