5 дней назад
Director, Clincial Operations (Clinical Operations)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clincial Operations (Clinical Operations): Leading global Phase I-IV clinical programs and ensuring trial delivery across timelines, budgets, quality standards, and regulatory requirements with an accent on CRO governance, cross-functional leadership, and clinical operations talent development. Focus on identifying and mitigating operational risks, maintaining ICH-GCP and global regulatory compliance, and driving complex studies from planning through execution.
Location: Europe and the US, with alignment to the US East Coast time zone. International travel of approximately 15% is expected.
Company
is a global pharmaceutical and healthcare company headquartered in Italy, focused on gastrointestinal health, rare and specialty segments, and innovative therapies.
What you will do
- Provide strategic and operational leadership for global Phase I-IV clinical programs.
- Plan, execute, monitor, and deliver clinical studies on schedule, within budget, and in compliance with quality and regulatory requirements.
- Partner with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and other functions.
- Lead CRO and vendor oversight, governance, contract management, budget control, and issue resolution.
- Drive feasibility assessments, risk mitigation, KPI monitoring, inspection readiness, and process improvements.
- Manage, coach, mentor, and develop Clinical Operations team members while presenting updates to senior leadership and external stakeholders.
Requirements
- Bachelor's degree in a scientific or health-related field; an advanced degree is preferred.
- 10+ years of Clinical Operations experience, including at least 5 years in a pharmaceutical or biotechnology sponsor organization.
- People management experience and a track record of developing clinical operations talent.
- Experience leading global Phase I-IV clinical trials and managing CROs, vendors, budgets, timelines, and study risks.
- Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
- Proficiency with eTMF, EDC, Veeva, and Microsoft Office; fluent English is required.
Culture & Benefits
- Culture centered on innovation, quality, accountability, collaboration, and continuous improvement.
- Competitive salary and comprehensive benefits.
- Professional growth and development opportunities.
- Inclusive environment focused on patients, science, and business success.
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