## [Sr Japan Program Clinical Head (CRM)\_シニア臨床開発リード(循環器・腎・代謝)](/req-10058282-sr-japan-program-clinical-head-crmshinialinchuangkaifaritoxunhuanqishendaixie-ja-jp "Sr Japan Program Clinical Head (CRM)_シニア臨床開発リード(循環器・腎・代謝)") Job ID REQ-10058282 Jul 05, 2026 LOC_JP ### 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](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 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: ### Role Requirements **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](https://www.novartis.com/about/strategy/people-and-culture "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)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) Division DIV_GD Business Unit Development Location LOC_JP Site 本社 Company / Legal Entity JP05 (FCRS = JP005) Novartis Pharma K.K. Functional Area FCT_RD Job Type Full time Employment Type Regular Shift Work No [Apply to Job](https://novartis.wd3.myworkdayjobs.com/ja-JP/Novartis_Careers/job/Japan-Program-Clinical-Head--CRM-_REQ-10058282-4 "Apply to Job") ![careers default image](https://prod1.jobapi.novartis.com.cn/themes/custom/cosmos/patterns/images/careers-default-image.webp "careers default image") Job ID REQ-10058282 ### Sr Japan Program Clinical Head (CRM)\_シニア臨床開発リード(循環器・腎・代謝) [Apply to Job](https://novartis.wd3.myworkdayjobs.com/ja-JP/Novartis_Careers/job/Japan-Program-Clinical-Head--CRM-_REQ-10058282-4 "Apply to Job")