노바티스에서 비임상 안전성(Preclinical Safety) 담당 시니어 사이언티스트를 채용합니다. 생명과학 석사 이상 학위와 GLP 환경에서의 독성 시험 경험이 필수입니다. 일본 내 신약 승인 신청(J-NDA) 및 임상 시험 계획서 작성, 당국 대응을 주도하며 글로벌 개발 프로젝트에 기여하게 됩니다. 비임상 가이드라인에 대한 깊은 이해와 유창한 일본어 및 영어 능력이 요구됩니다.
Job ID
REQ-10082103
Jul 02, 2026
Japan
で利用可能: 日本語
Drive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan.
Authoring responsible parts of J-NDAs, response to PMDA and all of the other activities for submission if necessary.
Assessment of pharmacological and/or toxicological profiles of early projects to contribute to Japan development strategy.
Roles as JPT/JST members
Support of TM clinical studies as pharmacologists and/or toxicologists including protocol/ICF review, IB review and interaction with HAs.
Seeking opportunity of proposals about new development programs/ indications
Participate/support initiatives, task-forces, and cross-functional activities in Dev./NPKK.
Quality management responsibility
Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
100% timely delivery of all training requirements including compliance
· Appropriate quality and timing of NDA and post NDA activities
· Appropriate quality and timing of pharmacological and/or toxicological profiling/evaluation of early projects
· Appropriate quality and timing of study supports
Education: MSc or PhD in life sciences (Pharmacology, toxicology, Pharmaceutics, other specific sciences), DVM/MD or equivalent professional experience.
· Experience/Professional requirement:
· Taking education or possessing knowledge of basic medicine, such as physiology, pharmacology, toxicology, anatomy/histology, molecular biology, etc.
· For mid-carrier employee, experience in pharmacology, toxicology or relevant field of the pharmaceutical Industry, CRO, academia, etc.
Appropriate skills of English (read/write and oral)
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Division
Biomedical Research
Business Unit
Development
Location
Japan
Site
Toranomon (NPKK Head Office)
Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
ノバルティス は 障害 を 持 つ 個人 と 協力 し、 合理的配慮 を 提供 することをお 約束 します。健康状態 や 障害 を 理由 に 採用 プロセス のいかなる 部分 においても、あるいは 職務 の 必須事項 を 果 たすた めに 合理的配慮 が 必要 な 場合 は midcareer-r.japan@novartis.com 宛 てに 電子 メール をお 送 りください。その 際 ご 依頼内容、 ご 連絡先、求人票 の 番号 を 明 してください。
Research & Development Biomedical Research Japan
Job ID
REQ-10082103
Job ID
REQ-10082103
