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4 дня назад

Director, Clinical Quality & Development Operations (Biotechnology)

184 000 - 276 000$
Формат работы
remote (только USA)/hybrid/onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director, Clinical Quality & Development Operations (Biotechnology): Leading operational excellence across global clinical operations, ancillary supply management, Phase 1 center alliances, safety distribution, and training programs with an accent on inspection readiness, regulatory compliance, and process standardization. Focus on developing cross-functional strategy, managing complex vendor and stakeholder relationships, resolving operational problems, and driving performance improvements across clinical development operations.

Location: Boston, Massachusetts, United States. The role is Remote-Eligible, with remote, hybrid, or on-site work options under Vertex's flex program.

Base salary: $184,000–$276,000 per year, plus potential annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and improved patient outcomes.

What you will do

  • Define and execute the operational excellence strategy for Global Clinical Operations and Clinical Quality & Development Operations.
  • Oversee ancillary supply management, Phase 1 center alliances, safety distribution, and training and development programs.
  • Maintain inspection readiness, regulatory compliance, process standardization, and operational effectiveness.
  • Manage strategic vendor relationships, including selection, performance monitoring, and risk mitigation.
  • Establish performance indicators and communicate compliance, efficiency, and strategy progress to senior leadership.
  • Lead complex cross-functional initiatives, resolve operational problems, and mentor staff and FSP employees.

Requirements

  • Bachelor of Science degree in a life sciences discipline.
  • Typically 10 years of experience, or an equivalent combination of education and experience, in the biopharmaceutical industry.
  • At least 3 years of supervisor or management experience, including significant line-management experience.
  • Advanced knowledge of GCP, CFR, ICH guidelines, and health authority regulations.
  • Significant experience in clinical quality activities and in-depth knowledge of clinical operations.
  • Strong leadership, analytical, communication, stakeholder-management, and cross-functional collaboration skills.

Culture & Benefits

  • Continuous learning focused on AI, technology, automation, and industry developments.
  • Medical, dental, and vision benefits with paid time off, including summer and winter company shutdowns.
  • Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
  • Remote, hybrid, or on-site work arrangements may be selected under the Flex @ Vertex program.

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