Сводка
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
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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
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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 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。
