4 дня назад
Director, Clinical Quality & Development Operations (Biotechnology)
184 000 - 276 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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