Director IPH

職務内容：

• 1. 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品質、コスト、納期（Quality, Cost, Timeline）の達成責任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
• 2. Clinical Managerのラインマネジメント
• Clinical Managerｍ、CRA層などの指導・育成します。
• 具体的には、採用、パフォーマンス評価、キャリア開発、コーチング、組織力向上を担当します。
• 3. リソースマネジメント
• 人員配置、ヘッドカウント管理、リソース予測、稼働率管理を行い、必要な人材を適切な試験へアサインします。
• 4. クライアントとの関係構築
• 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、契約範囲内での改善提案などを担当します。
• 5. 組織改善・プロセス改善
• SOP改善、KPI管理、Operational Excellence推進、業務効率化、品質向上施策

求める人物像

• 製薬企業、CRO、医療機関などの幅広いネットワークを有し、社内外のステークホルダーを巻き込みながら課題解決を推進できる方
• 経営層から現場まで幅広い層と信頼関係を構築し、組織横断的な調整・折衝ができる方
• 当事者意識を持ち、課題や問題に対してオーナーシップを発揮できる方
• 戦略立案に留まらず、必要に応じて自ら先頭に立って実行を推進できる方
• 現場の実態を理解し、実務レベルの課題解決にも主体的に関与できる方
• 自ら手本を示しながらチームを牽引できるリーダーシップを有する方
• 指示を待つのではなく、自ら課題を発見し、解決策の立案から実行まで主体的に推進できる方
• 日本法人およびグローバル双方との連携を通じて、組織目標の達成に向けたアラインメントを推進できる方
• 変化の大きい環境においても柔軟性と実行力を発揮し、組織成長を牽引できる方

職務経験等：必須要件

• 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

As a Director, Clinical Operations at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do: Your focus will be on driving clinical operations performance, ensuring quality, and building capability across your area. Key responsibilities include:

• Leading and overseeing the planning, execution, and management of clinical trials to ensure timely and successful completion.
• Providing strategic direction and guidance to cross-functional teams to optimize trial outcomes and meet project goals.
• Collaborating with key stakeholders to develop and implement innovative clinical trial strategies.
• Ensuring compliance with regulatory requirements and industry standards throughout the clinical trial process.
• Identifying and mitigating risks to ensure the integrity and quality of trial data.

Your Profile: You will bring significant clinical operations experience, with a track record of building high-performing teams and delivering results. Required qualifications and experience:

• 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%)

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.