Nonclinical Toxicology Study Monitoring Scientist
Vertex Pharmaceuticals
September 01, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Nonclinical Toxicology Study Monitoring Scientist (Boston Fan Pier / Hybrid)
Responsibilities:
- Partner with project toxicologists to develop, review, and operationalize protocols for nonclinical safety assessment studies (small and large molecule).
- Serve as primary monitoring contact for outsourced nonclinical studies at CROs/partners.
- Conduct on-site and remote monitoring to assess study conduct, data quality, protocol compliance, and GLP adherence.
- Identify/escalate issues and support resolution with CRO and internal teams.
- Prepare timely monitoring reports, visit summaries, and stakeholder communications.
- Track action items, decisions, and milestones; manage multiple concurrent studies/deliverables.
- Review monitoring reports/documentation and CRO performance metrics; support continuous improvement.
- Support CRO qualification (vendor assessment/audit support) and collaborate on quality review of regulatory documents.
- Apply digital/AI solutions to improve study planning, oversight, risk identification, communication, and knowledge/data sharing.
Qualifications & Skills:
- Hands-on in vivo lab experience (CRO or pharma/biotech).
- Experience supporting nonclinical safety assessment for both small and large molecule modalities.
- Working knowledge of GLP; strong organizational, multitasking, scientific/problem-solving, and communication skills.
- Ability to thrive in a fast-paced, matrixed environment; attention to detail.
Requirements:
- Travel 30%–50% for on-site monitoring/vendor interactions.
Preferred:
- Sponsor-facing study monitoring experience; direct CRO oversight/troubleshooting.
- Regulatory documentation familiarity; vendor qualification/audit support experience.
Education:
- Master’s (or equivalent) with 3+ years relevant experience, or Bachelor’s (or equivalent) with 4+ years relevant experience.
Comp/Benefits (high level):
- Annual bonus and annual equity awards; medical/dental/vision, paid time off, education assistance (incl. student loan repayment), commuting subsidy, matching charitable donations, 401(k).
Education/Experience + role pay range: $101,600–$152,400.
Responsibilities:
- Partner with project toxicologists to develop, review, and operationalize protocols for nonclinical safety assessment studies (small and large molecule).
- Serve as primary monitoring contact for outsourced nonclinical studies at CROs/partners.
- Conduct on-site and remote monitoring to assess study conduct, data quality, protocol compliance, and GLP adherence.
- Identify/escalate issues and support resolution with CRO and internal teams.
- Prepare timely monitoring reports, visit summaries, and stakeholder communications.
- Track action items, decisions, and milestones; manage multiple concurrent studies/deliverables.
- Review monitoring reports/documentation and CRO performance metrics; support continuous improvement.
- Support CRO qualification (vendor assessment/audit support) and collaborate on quality review of regulatory documents.
- Apply digital/AI solutions to improve study planning, oversight, risk identification, communication, and knowledge/data sharing.
Qualifications & Skills:
- Hands-on in vivo lab experience (CRO or pharma/biotech).
- Experience supporting nonclinical safety assessment for both small and large molecule modalities.
- Working knowledge of GLP; strong organizational, multitasking, scientific/problem-solving, and communication skills.
- Ability to thrive in a fast-paced, matrixed environment; attention to detail.
Requirements:
- Travel 30%–50% for on-site monitoring/vendor interactions.
Preferred:
- Sponsor-facing study monitoring experience; direct CRO oversight/troubleshooting.
- Regulatory documentation familiarity; vendor qualification/audit support experience.
Education:
- Master’s (or equivalent) with 3+ years relevant experience, or Bachelor’s (or equivalent) with 4+ years relevant experience.
Comp/Benefits (high level):
- Annual bonus and annual equity awards; medical/dental/vision, paid time off, education assistance (incl. student loan repayment), commuting subsidy, matching charitable donations, 401(k).
Education/Experience + role pay range: $101,600–$152,400.