7 часов назад
Head of Taiwan CSU (Clinical Study Units)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Head of Taiwan CSU (Clinical Study Units) (Clinical Development): Leading end-to-end clinical study delivery and the long-term CSU strategy in Taiwan with an accent on quality, regulatory compliance, resource planning, and stakeholder partnerships. Focus on optimizing study portfolios, developing high-performing teams, managing vendors and budgets, and using clinical intelligence, analytics, and digital capabilities to improve execution.
Location: Taipei, Taiwan
Company
develops medicines and therapies, with clinical research operations supporting innovative treatments and patient outcomes.
What you will do
- Lead the Taiwan Clinical Study Unit and ensure high-quality, efficient, and compliant clinical study execution.
- Optimize the study portfolio through resource planning, site strategy, recruitment forecasting, risk management, budget oversight, and performance monitoring.
- Develop the long-term CSU strategy and provide input on study planning, protocol optimization, feasibility, and clinical development.
- Build partnerships with investigators, hospitals, KOLs, Medical Affairs, regulatory functions, and other cross-functional stakeholders.
- Lead country operations, governance, inspection readiness, regulatory submissions, contracts, translations, and vendor activities.
- Coach and develop the CSU team while managing budgets, vendors, resource allocation, and operational performance.
Requirements
- Advanced degree in Life Sciences, Medicine, Pharmacy, or a related scientific discipline, such as MSc, MD, PharmD, or PhD.
- At least 10 years of clinical research experience, including at least 3 years of people management experience.
- Strong knowledge of clinical development, ICH-GCP, and global and local clinical trial regulations.
- Proven leadership, stakeholder influence, change management, coaching, risk management, and decision-making skills.
- Experience with clinical analytics, digital tools, project management, and vendor management.
- Excellent written and verbal communication skills in English and the local language.
Nice to have
- Experience in Regulatory Affairs, Market Access, Medical Affairs, or external vendor management.
Culture & Benefits
- Focus on ethics, quality, patient-centricity, and Health, Safety & Environment.
- Commitment to continuous improvement, capability building, collaboration, and continuous learning.
- Equal-opportunity environment with an emphasis on inclusion and diverse perspectives.
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