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."
Show more Show less
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000The position has responsibility for nonclinical safety profiling and characterization of development candidates. · We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex,Comprehensiv ...
-
Tsukuba, Ibaraki Astellas PharmaThe position has responsibility for nonclinical safety profiling and characterization of development candidates while reporting to Applied Safety (AS) Head/AS-JP Head, Applied Research & Nonclinical Safety (ARNCS). · Preparation of nonclinical safety development plansProvision of ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000We are seeking a Scientist II – Genotoxicity Expert to join our team at Astellas Pharma in Tsukuba, Japan.We require a highly skilled professional with expertise in genotoxicity assessment and risk of carcinogenesis evaluation. · ...
-
Plant Engineer
2ヶ月前
Tsukuba Covestro Full time+We refine chemical material solutions with game-changing products. · +High school graduate or above · +Equipment management and related tasks for the optical fiber UV-curable coating material manufacturing plant - General maintenance and inspection of production equipment used a ...
-
Plant Engineer
2ヶ月前
Tsukuba CovestroWe are Covestro. We are curious. We are courageous. We are colorful. · Equipment management and related tasks for the optical fiber UV-curable coating material manufacturing plant - General maintenance and inspection of production equipment used at the Tsuchiura Plant (Preventiv ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000+Design and develop a prototype potency assay, · +Collaborate with related functions, · +Maintain and update scientific knowledge on novel technologies, · +Provide regular reports.This position is based in Tsukuba in Japan. · ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000Astellas aims to create a robust R&D portfolio utilizing cutting-edge science and technology. · We are seeking a scientist to advance antibody engineering projects within our global Antibody Engineering group under Biologics Engineering unit in Tsukuba, Japan. · ...
-
Tsukuba Spring HealthWe are seeking qualified part-time internationally licensed psychotherapists to join our provider network and deliver care with a tech-enabled AI/machine-learning platform that puts patient outcomes first. · Provide counseling to clients with benefits ranging from short-term goal ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000This is a pharmacologist position developing antibody therapeutics, such as T cell engager for treating cancer based on deeper understanding of modulating T cell activation.Plan and conduct non-clinical pharmacological studies, including animal studies. · Work in a team-oriented ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000We are seeking a Pharmacologist for our Immune Cell Modulation Product Creation team. · We are looking for an experienced pharmacologist with expertise in antibody therapeutics development and T cell activation modulation. · The position holder will have responsibility of own pha ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000This pharmacologist position develops anti-cancer drugs including antibody-drug conjugates ADCs multi-specific antibodies or engineered small molecules. · Plan and independently conduct appropriate non-clinical pharmacological studies including animal works necessary to promote t ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000The position provides strategic guidance on optimizing candidates' pre-formulation/physicochemical properties/ADME. · ...
-
Tsukuba アステラス製薬We are seeking a Toxicologist for our Exploratory Pathophysiology team. The successful candidate will have expertise in genotoxicity and related regulatory science. · The Toxicologist will provide scientific and technical support with genotoxic elucidation and strategy building w ...
-
Tsukuba アステラス製薬 ￥50,000 - ￥100,000This is a pharmacologist position developing antibody therapeutics, such as T cell engager, for treating cancer based on the deeper biological understanding of modulating T cell activation. · ...
-
Tsukuba, Ibaraki Astellas PharmaUnder supervision of senior toxicologists execute genotoxicity assessment plans preparation nonclinical safety sections Investigator Brochures Briefing Documents INDs NDA responses regulatory authorities collect promote research advocacy smooth promotion internal programs support ...
-
Tsukuba, Ibaraki Astellas Pharma ￥4,000,000 - ￥10,000,000 per yearThe formulation and ADME drives the optimization of drug candidates through globally competitive formulation development. This role provides strategic guidance on the optimization of drug candidates. · Act as an outstanding scientist of discovery safety team. · ...
-
Tsukuba, Ibaraki Astellas PharmaWe are looking for individuals who can add values to Oncology Research. · ...
-
Tsukuba, Ibaraki Astellas PharmaAstellas aims to create strong R&D portfolio with world-class science and technology, · and Innovation Lab is strengthening research capabilities with a particular focus on selected non-oncology diseases. · This position conducts experiments generates data engages in scientific d ...
-
Plant Engineer
1ヶ月前
Tsukuba, Ibaraki CovestroWe are Covestro. We are curious. We are courageous. We are colorful. We refine chemical material solutions with game-changing products. · General maintenance and inspection of production equipment used at the Tsuchiura Plant (Preventive maintenance, troubleshooting, etc.) · Produ ...
-
Tsukuba, Ibaraki Astellas PharmaThis position applies cellular and molecular biology expertise to contribute to the design and development of a prototype potency assay aimed at evaluating AAV quality. · ...
-
Tsukuba, Ibaraki Astellas Pharma ￥3,000,000 - ￥6,000,000 per yearAstellas aims to create strong R&D portfolio with world-class science and technology. · ...
