転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です
[Innovative Medicine] R＆D, Specialist/Manager, Clinical Pharmacology, Clinical Pharmacology ＆ Pharmacometrics Japan
年収：800万 ～ 1300万
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | [Innovative Medicine] R＆D, Specialist/Manager, Clinical Pharmacology, Clinical Pharmacology ＆ Pharmacometrics Japan |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. ■Objective of Position The Clinical Pharmacology (CP) Senior Scientist role within Japan Clinical Pharmacology and Pharmacometrics (CPP) is to apply and promote CP knowledge, including pharmacokinetics (PK) / pharmacodynamics (PD) analyses and principles of model-based drug development in the programs for all stages of drug development in Japan. The responsibilities of this position include contribution in Japan Project Teams independently. ■Main Accountabilities Responsible for clinical study plan, PK and PK/PD analysis, and documentation of a Japanese Phase 1 study Designs and writes clinical study protocols, analysis plans, and clinical reports of a Japanese phase I study or more complex CP study with mentoring Responsible for clinical development strategy, clinical study design/protocol development, PK and PK/PD analysis, and documentation from CP perspective in the assigned project(s) in Japan With mentoring, conduct data analysis and reporting of common CP contributions (e.g., PK, PD, immunogenicity) of clinical studies in Japan Integrates all available data (both clinical and nonclinical data) to clinical development strategy from CP point of view Evaluates and applies new data and data analyses to refine studies in the development plan Responsible for clinical pharmacology data package for Japan NDA and responding to regulatory authority queries in the assigned project(s) Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles Other Accountabilities & Tasks Collaborate with the Pharmacometrics leaders in overall CP development strategy, the design of clinical studies including modeling and simulation-based assessments for drug development in Japan Translate quantitative knowledge into strategic opportunities with key stakeholders to drive development along with the model-based drug development principles With mentoring, present at review /advisory / governing meetings with global CPL (e.g. CPP Review, MIDD Brainstorm) With mentoring, author CP section of regulatory documents for J-NDA submission, responses to regulatory questions, and other types of interactions in Japan With mentoring, represent CPP at regulatory interactions in Japan Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals as a member of Japan Project Team Apply appropriate regulatory (e.g., MHLW, ICH etc.) guidelines in the design of clinical development plans and studies in Japan Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact |
| 応募資格 |
【必須（MUST）】 ■Minimum Qualifications / ExperiencePhD or equivalent with minimum 2 years of relevant experiences; or MS or equivalent with minimum 6 years of relevant experience; or, equivalent level of expertise and the experience Good knowledge and experience of drug development in one or multiple TAs ■Minimum Technical Knowledge and Skills Comprehensive understanding of requirements for various regulatory documents in Japan Knowledge of drug development, regulatory requirements and guidelines expanded to multiple therapeutic modalities, to handle routine and non-routine work for FDA and EMA in addition to PMDA / MHLW Ability to build and maintain effective working relationship inside and outside the department; ability and willingness to work in a cross-functional team environment Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) Ability to interpret PK and PK/PD results and prepare presentations to communicate findings effectively Strong oral and written communication skills in both Japanese and English ■Other Requirements Estimated both domestic and international travel of about 5% of time |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2026/02/06 |
| 求人番号 | 7231896 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です