Director, Clinical Operations
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Job Description
Clinical operations director leading clinical trials, regulatory compliance, and team capability at ICON, a global healthcare intelligence and clinical research organisation.
Responsibilities:
- 臨床試験オペレーション全体の戦略・運営管理
- 担当領域や地域の臨床試験実行を統括し、品質、コスト、納期（Quality, Cost, Timeline）の達成に責任を持つ
- 試験実施上のリスク管理とエスカレーション
- プロジェクトやプログラムの実行戦略策定
- Clinical Manager、CRA層などの採用、パフォーマンス評価、キャリア開発、コーチング、組織力向上
- 人員配置、ヘッドカウント管理、リソース予測、稼働率管理、試験への人材アサイン
- クライアント幹部との定例会議、パフォーマンスレビュー、問題発生時のエスカレーション対応、改善提案
- SOP改善、KPI管理、Operational Excellence推進、業務効率化、品質向上施策
- Design and analyse clinical trials, interpreting complex medical data, and contribute to innovative treatments and therapies
- Lead and oversee the planning, execution, and management of clinical trials
- Provide strategic direction and guidance to cross-functional teams
- Collaborate with stakeholders to develop and implement clinical trial strategies
- Ensure compliance with regulatory requirements and industry standards
- Identify and mitigate risks to ensure trial data integrity and quality
Requirements:
- 臨床開発におけるラインマネジメント経験
- ビジネスレベルの英語力： Global Stakeholdersと電話会議/ビデオ会議でディスカッションできるレベル
- Bachelor's degree in life sciences or related field; advanced degree preferred
- Extensive experience in clinical operations within the pharmaceutical, biotechnology, or CRO industry
- Proven track record of successfully leading and managing clinical trials from start to finish
- Strong understanding of regulatory requirements and GCP guidelines
- Excellent communication, leadership, and problem-solving skills
- Willingness to travel as required (approximately 20%)
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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