Associate or Manager, Japan Program Clinical Head
Novartis
Associate or Manager, Japan Program Clinical Head
Job Description
Summary
Summary ・The Japan Program Clinical Head (JPCH) is responsible for clinical programactivities for approval and post approval commitment for Re-examination in Japan・The JPCH leads disease area strategy discussion and the risk-benefit assessments for the programs(s) that are required for approval in Japan
・The JPCH is accountable for the study design, implementation, and execution of clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view, as a member of Global Clinical Team(s) (GCT) and the leader of Japan Clinical Team(s) (JCT)
Locations
- Japan
Salary
Estimated Salary Rangemedium confidence
50,000 - 85,000 USD / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- 臨床プログラム管理 (clinical program management)intermediate
- 疾患領域戦略立案 (disease area strategy development)intermediate
- リスクベネフィット評価 (risk-benefit assessment)intermediate
- 臨床試験デザイン (clinical study design)intermediate
- 臨床試験実施・実行 (clinical study implementation and execution)intermediate
- リーダーシップ (leadership)intermediate
- グローバルチームコラボレーション (global team collaboration)intermediate
- 規制要件対応 (regulatory compliance)intermediate
- 市場アクセス戦略 (market access strategy)intermediate
Required Qualifications
- 臨床開発経験 (experience in clinical development) (experience)
- Japan Program Clinical Headレベルの専門性 (expertise at JPCH level) (experience)
- Global Clinical Teamメンバー資格 (qualification for GCT membership) (experience)
- Japan Clinical Teamリーダーシップ (leadership for JCT) (experience)
Responsibilities
- 日本での承認・再審査用臨床プログラム活動の責任 (responsibility for clinical program activities for approval and post-approval re-examination in Japan)
- 疾患領域戦略議論のリード (leading disease area strategy discussions)
- プログラムのリスクベネフィット評価 (risk-benefit assessments for programs)
- 臨床開発プログラムの試験デザイン・実施・実行 (study design, implementation, and execution of clinical development programs)
- Global Clinical Teamメンバーとして意思決定支援 (supporting decision milestones as GCT member)
- Japan Clinical Teamリーダー (leading JCT)
- 規制要件・市場アクセス対応 (addressing regulatory requirements and market access from Japan perspective)
Answer 10 quick questions to check your fit for Associate or Manager, Japan Program Clinical Head @ Novartis.
10 Questions
~2 Minutes
Instant Score
Associate or Manager, Japan Program Clinical Head
Novartis
Associate or Manager, Japan Program Clinical Head
Job Description
Summary
Summary ・The Japan Program Clinical Head (JPCH) is responsible for clinical programactivities for approval and post approval commitment for Re-examination in Japan・The JPCH leads disease area strategy discussion and the risk-benefit assessments for the programs(s) that are required for approval in Japan
・The JPCH is accountable for the study design, implementation, and execution of clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view, as a member of Global Clinical Team(s) (GCT) and the leader of Japan Clinical Team(s) (JCT)
Locations
- Japan
Salary
Estimated Salary Rangemedium confidence
50,000 - 85,000 USD / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- 臨床プログラム管理 (clinical program management)intermediate
- 疾患領域戦略立案 (disease area strategy development)intermediate
- リスクベネフィット評価 (risk-benefit assessment)intermediate
- 臨床試験デザイン (clinical study design)intermediate
- 臨床試験実施・実行 (clinical study implementation and execution)intermediate
- リーダーシップ (leadership)intermediate
- グローバルチームコラボレーション (global team collaboration)intermediate
- 規制要件対応 (regulatory compliance)intermediate
- 市場アクセス戦略 (market access strategy)intermediate
Required Qualifications
- 臨床開発経験 (experience in clinical development) (experience)
- Japan Program Clinical Headレベルの専門性 (expertise at JPCH level) (experience)
- Global Clinical Teamメンバー資格 (qualification for GCT membership) (experience)
- Japan Clinical Teamリーダーシップ (leadership for JCT) (experience)
Responsibilities
- 日本での承認・再審査用臨床プログラム活動の責任 (responsibility for clinical program activities for approval and post-approval re-examination in Japan)
- 疾患領域戦略議論のリード (leading disease area strategy discussions)
- プログラムのリスクベネフィット評価 (risk-benefit assessments for programs)
- 臨床開発プログラムの試験デザイン・実施・実行 (study design, implementation, and execution of clinical development programs)
- Global Clinical Teamメンバーとして意思決定支援 (supporting decision milestones as GCT member)
- Japan Clinical Teamリーダー (leading JCT)
- 規制要件・市場アクセス対応 (addressing regulatory requirements and market access from Japan perspective)
Answer 10 quick questions to check your fit for Associate or Manager, Japan Program Clinical Head @ Novartis.
10 Questions
~2 Minutes
Instant Score