【募集の背景 / Purpose & Scope】

Under supervision of senior toxicologists, the position has responsibility for genotoxicity and risk of carcinogenesis assessment to provide scientific and technical support with genotoxic elucidation and strategy building in project teams that includes the design, analysis, assessment and reporting of genotoxicity studies, as well as for collecting scientific information/promoting research advocacy necessary for smooth promotion of internal programs, while reporting to Applied Safety (AS) Head/AS-JP Head, Applied Research & Nonclinical Safety (ARNCS).

【職務の内容 / Essential Job Responsibilities】

(雇入れ直後)

・Under supervision of senior toxicologists, execute genotoxicity and risk of carcinogenesis assessment:

Preparation of genotoxicity and risk of carcinogenesis assessment plans
Provision of genotoxicity expert input to the development strategy of Astellas compounds
Preparation of nonclinical safety sections of Investigator Brochures, Briefing Documents, INDs and NDAs, and responses to queries from regulatory authorities

・Collect information and promote research advocacy necessary for smooth promotion of internal programs

・Support promoting nonclinical research and be accountable for information on genotoxic concerns arising from targets and modalities

・Implement a new evaluation system with the consent of stakeholders

・Provide expert input for decision-making regarding genotoxicity and risk of carcinogenesis in each project

・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.

・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>

・Master's Degree- Knowledge of drug development and nonclinical research

・5+ years experiences in genotoxicity studies and regulatory science for genotoxicity as study director.

・Leading expertise in genotoxicity

・Communicating skills (active & passive) in own language and in English

<歓迎 / Preferred>

・PhD in toxicology, biochemistry, pharmacology, genetics, molecular/cell biology or related sciences

・Knowledge in ICH M7, Q3 and S9, ISHL GLP, chemical structure or molecular genetics.

・Knowledge or experience of drug development, especially IND and NDA

・Member in JEMS or community under JEMS

・Expertise in use of in silico tools for genotoxicity prediction

・Robust leadership skills or human network especially in strong connection with genotoxicity or carcinogenicity KOLs

【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 → 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

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)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【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-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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