The position has responsibility for nonclinical safety profiling and characterization of development candidates, implementing nonclinical safety data packages (including plan, execution, outsourcing, and evaluation of toxicity studies), documentations, and regulatory responses, and for enabling regulatory interactions, while reporting to Applied Safety (AS) Head/AS-JP Head, Applied Research & Nonclinical Safety (ARNCS).
(雇入れ直後)
・ Execute Nonclinical Safety Program Management
Preparation of nonclinical safety development plans
Provision of nonclinical safety information to global PJ teams
Preparation of nonclinical safety sections of Investigator Brochures, Briefing Documents, INDs and NDAs, and responses to queries from regulatory authorities
・ Collaborate closely with other internal stake holders 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 nonclinical safety perspectives and provide safety data and rationale in post-marketing clinical trials, if necessary
・ Execute assessment of nonclinical 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.
・ Collect and accumulate 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 nonclinical 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.
(変更の範囲)
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements 】
This position is based in Tsukuba Miyukigaoka and will require on-site work.
【応募要件 / Qualifications 】
<必須 / Required >
・ 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
・ Extensive knowledge and experience in toxicological pathology for drug R&D
<歓迎 / Preferred >
・ PhD in toxicology, biochemistry, pharmacology, pharmaceutical or related sciences with 5 years work experience
・ Robust human network
・ Understanding R&D policy / strategy of Astellas
・ Knowledge or experience of drug development, especially IND and NDA
・ Leadership and team management skill
・ Board certification in toxicology/veterinary pathology.
【応募書類 / Application Documents 】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed
【選考プロセス / Selection details 】
書類選考 → 1 次面接 →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 → 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)
会社の定める事業場および自宅
【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
③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
① Base salary: will be decided by the candidate's experience, skill and capability.
② When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000 ~ 100,000yen, based on the Grade)
③ When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
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-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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