Summary
本ポジションは、日本における臨床開発をリードし、革新的な医薬品を患者さんへ届ける重要な役割です。
Japan Program Clinical Head（JPCH）は、日本市場における開発戦略の中核として、グローバルチームと連携しながら、臨床試験の設計・実行・承認取得および再審査対応までを担います。
Working closely with the Global Program Clinical Head (GPCH) and Japan Project Head (JPH), you will shape clinical strategies, contribute to benefit-risk assessments, and ensure successful regulatory approval and market access in Japan.
About the Role
Key Responsibilities / 主な業務内容
- Represent Clinical Development Japan in Global Clinical Teams (GCT)
GCTのエクステンデッドメンバーとして日本を代表 - Lead Japan clinical development within Japan Project Team (JPT)
JPTメンバーとして日本の臨床開発をリード - Drive Japan strategy and execution post-development decision point
DDP後、日本の臨床戦略と実行をリード - Contribute to global Clinical Development Plans aligned with Target Product Profile
グローバル開発計画（CDP）に日本視点で貢献 - Lead clinical inputs for protocols, study reports, and regulatory documentation
試験計画書・CSR・承認関連資料の作成に責任を持つ - Act as medical lead for Japan-initiated studies
国内主導試験のメディカルリードを担当 - Engage with external stakeholders including regulatory authorities and key opinion leaders
規制当局やKOLとの重要な外部連携 - Support regulatory submissions, re-examination, and lifecycle management
承認申請・再審査・ライフサイクルマネジメントを支援 - Contribute to therapeutic area strategies (e.g. Rheumatology)
疾患領域戦略（例：リウマチ）に貢献 - Coach and mentor team members while fostering development culture
チーム育成・カルチャー形成に貢献
Essential Requirements / 必須要件
- Advanced degree in life sciences or healthcare (MD, PhD, PharmD preferred)
ライフサイエンスまたは医療分野の上級学位（MD/PhD/PharmD歓迎） - 5+ years of experience in clinical development across Phase I–IV
臨床開発（第I–IV相）で5年以上の経験 - Strong knowledge of GCP, clinical trial design, and development processes
GCP・試験デザイン・開発プロセスの深い理解 - Experience with regulatory submissions and health authority interactions
承認申請および当局対応の経験 - Proven leadership and cross-functional collaboration skills
リーダーシップおよびクロスファンクショナル連携能力 - Strong communication, negotiation, and problem-solving skills
高いコミュニケーション・交渉・問題解決能力 - Business-level English (oral and written)
ビジネスレベルの英語力
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 diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Additional Information
Be aware of fake job advertisements and job offers. Novartis does not make job offers without interviews and never asks candidates for money. All our current job openings are displayed here. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money, or provide personal information.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
利便性と合理的配慮
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 [email protected] 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。
