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[Innovative Medicine] R＆D, Senior Principal Scientist, Pharmacology Group, Preclinical Science ＆Translational Safety Japan
年収：1000万 ～ 1500万
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, Senior Principal Scientist, Pharmacology Group, Preclinical Science ＆Translational Safety Japan |
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| 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. Job Description: As a Principal/Senior Principal Scientist responsible for nonclinical submissions within Preclinical Science and Translational Safety (PSTS), you will integrate nonclinical data—including toxicology, safety pharmacology, and DMPK—and lead the high‑quality and timely preparation and review of nonclinical sections for regulatory submission documents intended for global health authorities. You will collaborate with internal and external experts to develop clear scientific narratives and risk assessments, and work closely with the global dossier team to contribute to pipeline advancement across therapeutic areas JOB SUMMARY: 1. Conduct 1) to 4) below in the non-clinical area with global mind set. 1) Ensure appropriate studies are conducted at appropriate times to support drug development in Japan 2) Ensure study results and their interpretation meet Japanese regulatory requirements. 3) Ensure resolution to all project-related problems that might affect development in Japan. 4) Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines by using modern approaches, including AI. 2. Focus on self-evaluation, self-management and self-development. 3. Scientific educate and coach the members. 4. Make close/tight relationships with Global team and plan/execute strategy of scientific/regulatory matters 5. Shape regulatory acceptance aligned with international standards through external/industry activities. KEY RESPONSIBILITIES: 1. Conduct 1) to 9) below in the non-clinical area with global mind set. 1) Research global documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDAs. 2) Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice. 3) Prepare high-quality non-clinical documents for clinical studies and/or NDAs by using modern approaches, including AI. 4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with Global, JPKK and/or external experts. 5) Provide support for preparing high-quality documents for marketing. 6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed. 7) Provide relevant colleagues with suggestions from non-clinical perspectives. 8) Establish, maintain and improve relationships to relevant colleagues and external experts. 9) Support the members, and check the documents and/or responses prepared by the members in terms of science and quality 10) Use sound scientific and logical justifications to bring PMDA acceptance more aligned with ICH guidelines and other major Global HA (e.g. FDA, EMEA, CDE, etc.) to minimize the amount of work required specifically for Japan approvals. 2. Give scientific feedback and coaching to the members and support development of members. |
| 応募資格 |
【必須（MUST）】 ■Experience/Knowledge- Expert knowledge of the non-clinical area (strong background in biology, toxicology, pharmacology, DMPK), advanced knowledge of non-clinical notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, advanced knowledge of other non-clinical areas, and intermediate knowledge of clinical areas. - Experience in non-clinical areas for more than 15 years or equivalent to the experience. - Experience with activities outside the company or department ■Skills/Capabilities - Advanced presentation and negotiation skills with global mindset. - Advanced communication skills in English. - Advanced scientific skills in managing and developing the group members, including coaching, feedback and mentoring. ■Advance negotiation and influencing skills Challenges the status quo and embraces new ways of doing things 【歓迎（WANT）】 Clinical Data Management, Drug Discovery Development, EHS Compliance, Emergency Planning, Performance Measurement, Presentation Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Strategic Thinking, Tactical Planning, Technical Credibility |
| 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 | 7231113 |
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