Job Description Summary
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.
Job Description
職務内容
- 非臨床安全性担当者としてプロジェクトチームに参画しチームメンバーと協働し開発を推進する。
- Globalメンバーの一員として，国内外の開発に非臨床安全性担当者として貢献する。
主な役割責任
- 早期化合物の安全性評価を行いチームへ適切に評価内容を伝える。
- 承認申請資料を作成し，当局からの照会回答を含む承認申請全般に責任をもつ。
- 治験届に関する資料作成を行い，当局からの照会対応を含む治験届業務全般に責任をもつ。
- 当局に対する相談について非臨床安全性担当者として責任をもつ
必須要件
- ライフサイエンス分野で修士以上，もしくはそれと同等の学位を有する（PhD, DVM等）。
- 非臨床安全性分野での業務経験を有する。GLP環境下での毒性試験経験，または委託試験経験を有する。
- 国内外の非臨床安全性に関するガイドラインを周知しており，活用できる。
- 日本語は母国語相当及び英語は流暢(口頭および書面)
望ましい要件
- 放射線治療薬，遺伝子治療薬，細胞医療等製品，又は核酸医薬品等の最新のモダリティーの毒性評価の経験を有する。
- 生殖発生毒性試験や毒性病理，遺伝毒性など毒性学的専門領域を有する。
- AIを用いた毒性評価経験
Major Accountabilities
· 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
Key Performance Indicators
· 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
Background
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.
English Skill:
Appropriate skills of English (read/write and oral)
Benefits and Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Additional Information
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Skills Desired
Animal Models, Bioinformatics, Collaboration, Data Analysis, Ethics, Problem Solving, Regulatory Compliance, ToxicologySkills Required
- MSc or higher in life sciences (PhD, DVM or equivalent)
- Experience in nonclinical safety (toxicology/pharmacology) including GLP toxicology studies or outsourced study experience
- Familiarity with domestic and international nonclinical safety guidelines and ability to apply them
- Japanese native-level proficiency and fluent English (written and oral)
- Knowledge/education in basic medicine (physiology, pharmacology, toxicology, anatomy/histology, molecular biology)
- Experience in pharmacology, toxicology or relevant field in pharmaceutical industry, CRO, or academia
- Experience in toxicity evaluation for radiopharmaceuticals, gene/cell therapies, or nucleic acid therapeutics
- Expertise in reproductive/developmental toxicity, toxicologic pathology, or genotoxicity
- Experience using AI for toxicity assessment
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
