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5 дней назад

Director, Clincial Operations (Clinical Operations)

Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
c1
Страна
US/Europe
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

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Описание вакансии

Текст:
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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

hirify.global 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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