PK/ADME Scientist, Applied Drug Metabolism & Pharmacokinetics

General Information

• Job Advert Title: PK/ADME Scientist, Applied Drug Metabolism & Pharmacokinetics
• Location: Tsukuba, Ibaraki
• Division: Early Development and Translational Science
• Employment Class: Permanent

Description

【募集の背景 / Purpose & Scope】非臨床安全性＆開発研究　応用動態では、非臨床薬物動態研究の専門家として、一人でも多くの患者さんの手もとにいち早く革新的な新薬を届けるために様々なResearch & Development部門と協働して製品創出の効率向上や高質な製品創出を担っています。本ポジションでは、以下の薬物動態研究戦略の立案・実行に意欲のある研究員を募集します。・創薬研究での開発候補化合物選択からInvestigational New Drug (IND)にむけた開発研究、そして医薬品申請まで幅広い範囲で必要な科学的根拠に基づいた高質な非臨床薬物動態試験・様々なモダリティの薬物動態把握のためのバイオアナリシス、データサイエンスおよびレギュラトリーサイエンスを含めた最先端の薬物動態研究プラットフォームの強化および開発
In Applied Drug Metabolism & Pharmacokinetics (Applied DMPK), Applied Research & Nonclinical Safety, we are experts in nonclinical pharmacokinetic research and are responsible for improving the efficiency of product creation and creating high-quality products by collaborating with various Research & Development departments to bring innovative new drugs into the hands of as many patients as possible as quickly as possible.We are seeking researchers who are enthusiastic about planning and executing the following pharmacokinetic research strategies for this position:・Conducting high-quality non-clinical pharmacokinetic studies based on scientific evidence across a wide range, from candidate compound selection in early drug discovery research to development research leading to Investigational New Drug (IND) application and ultimately to drug approval・Strengthening and developing cutting-edge pharmacokinetic research platforms, including bioanalysis, data science and regulatory science, to understand the pharmacokinetics profiles of various modalities

【職務の内容 / Essential Job Responsibilities】（雇入れ直後）- 非臨床薬物動態研究の代表として、global PJチームに参画し、開発候補化合物選択、INDおよびNew Drug Application/Biologics License Application (NDA/BLA)のための非臨床薬物動態研究およびレギュラトリーサイエンスの戦略的計画を立案・実行する- NDA/BLAに向けたCommon Technical Document (CTD)などの規制文書の作成および規制当局との非臨床薬物動態に関する照会対応を遂行する- 最先端の薬物動態研究とレギュラトリーサイエンスを最大限に活用し、非臨床および臨床段階の研究課題の要因を解明する- アステラス製薬社内のResearch & Development部門および社外の研究機関（CRO、アカデミア）と良好な協力関係を構築し、グローバルに連携する。
- Participate as a representative of nonclinical DMPK research in global cross-functional PJ team to select development candidate compounds, and to develop and execute strategic planning of nonclinical DMPK research and regulatory science for IND and New Drug Application/Biologics License Application (NDA/BLA)- Prepare regulatory documents such as Common Technical Document (CTD) for IND and NDA/BLA, and respond to inquiries with regulatory authorities regarding non-clinical pharmacokinetics- Maximum use of cutting-edge PK science and regulatory science incorporated to understand causal pathways for preclinical and clinical research questions- Establish good working relationships and collaboration with Astellas' internal R&D functions and external research organizations (CROs and academia) on a global basis
（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】At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

【応募要件 / Qualifications】＜必須 / Required＞- Master’s Degree and Minimum of five (5) years’ experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology- High professional level of knowledge and skill in pharmacokinetics and analytical science- Skill of the preparation of regulatory documents- Presentation /recommendation skills for decision making of PJ/themes- Experience of CRO management- Coordination skills and strategic thinking- Lead skills of team activities with multi-functional /regional /cultural members- Ability to overcome difficulties with enthusiasm and passion- Global communication skills with sensitivity and diplomacy
＜歓迎 / Preferred＞An MD, PhD or PharmD is preferable with a specialty in pharmaceutical and/or pharmacokinetics science.- Experience in pharmacokinetic evaluation of various modalities such as modified antibodies, cell therapy, and gene therapy- Experience in managing global development projects- Research and work experience abroad- Experience in early drug discovery ADME screening- Experience in measuring drug concentrations in biological samples- Experience in mathematical analysis such as PK-PD analysis

【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-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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