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1 день назад

Nonclinical Toxicology Study Monitoring Scientist (AI)

101 600 - 152 400$
Формат работы
remote (только USA)/hybrid/onsite
Тип работы
fulltime
Грейд
middle
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
Nonclinical Toxicology Study Monitoring Scientist (AI/nonclinical safety): Providing scientific and operational oversight for outsourced toxicology and nonclinical safety studies involving small molecules, large molecules, and cell and gene therapies with an accent on GLP compliance, data quality, CRO collaboration, and study execution. Focus on monitoring multiple concurrent studies, identifying and resolving operational and scientific risks, supporting regulatory documentation, and applying digital and AI-enabled solutions to improve study oversight.

Location: Boston Fan Pier, Massachusetts; remote, hybrid, or on-site work options are available under the Flex @ Vertex program. The role requires 30%–50% travel for on-site study monitoring visits and vendor interactions.

Base salary: $101,600–$152,400 annually, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and therapies for patients.

What you will do

  • Partner with project toxicologists and cross-functional stakeholders to develop, review, and operationalize protocols for nonclinical safety studies.
  • Monitor outsourced toxicology and nonclinical safety studies at CROs and partner organizations through on-site visits and remote oversight.
  • Assess study conduct, data quality, protocol compliance, GLP adherence, risks, timelines, and deliverables.
  • Identify, escalate, and help resolve scientific, technical, operational, and study execution issues with CROs and internal stakeholders.
  • Prepare monitoring reports, visit summaries, stakeholder communications, and follow-up documentation.
  • Support CRO qualification, vendor assessments, audit activities, performance management, and regulatory document review.

Requirements

  • Master’s degree in life sciences or a related scientific field with 3+ years of relevant experience, or bachelor’s degree with 4+ years of relevant experience.
  • Hands-on in vivo laboratory experience in a CRO, pharmaceutical, or biotechnology setting.
  • Experience with nonclinical safety assessment involving both small and large molecule modalities, including cell and gene therapies.
  • Working knowledge of Good Laboratory Practice regulations and sponsor oversight expectations.
  • Strong scientific, problem-solving, organizational, multitasking, interpersonal, and written and verbal communication skills.
  • Willingness and ability to travel 30%–50% for on-site monitoring visits and vendor interactions.

Nice to have

  • Experience monitoring outsourced toxicology or nonclinical safety studies in a sponsor-facing role.
  • Experience with CRO oversight, vendor qualification, audit support, or CRO performance management.
  • Experience with regulatory documentation and nonclinical submission sections.
  • Experience using digital tools, dashboards, or AI-assisted technologies to improve study oversight and operational efficiency.

Culture & Benefits

  • Flexible work designation allowing remote, hybrid, or on-site arrangements.
  • Medical, dental, and vision benefits with paid time off and summer and winter company shutdowns.
  • Educational assistance programs, including student loan repayment.
  • Commuting subsidy, matching charitable donations, and 401(k) benefits.
  • Collaborative work with internal scientific teams, CRO partners, vendors, and cross-functional stakeholders.

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