Nonclinical Toxicology Study Monitoring Scientist

Job Description General Summary: We are seeking a Nonclinical Toxicology Study Monitoring Scientist to play a critical role in supporting the safety assessment of both large and small molecule modalities including cell and gene therapies across the development pipeline by providing scientific, technical, and operational oversight of outsourced nonclinical studies. This individual will partner closely with project toxicologists, cross-functional internal teams, and external Contract Research Organizations (CROs) to help ensure studies are executed to high scientific and operational standards, in alignment with study objectives, timelines, and regulatory expectations. This role is best suited for a scientifically grounded, highly organized, collaborative study monitor who thrives in a fast-paced environment, excels at managing multiple studies and competing priorities simultaneously, and communicates clearly and succinctly to drive study execution and decision-making. This role is a scientific and operational study monitoring position, not a Quality Assurance role. While partnership with QA and attention to compliance are important, the primary focus is on study monitoring, scientific oversight, CRO partnership, issue resolution, organization, and cross-functional communication in support of nonclinical program execution. This role is central to ensuring that nonclinical safety studies are conducted with scientific rigor, operational excellence, and effective external oversight. The Nonclinical Toxicology Study Monitoring Scientist helps generate the high-quality data needed to inform development decisions and advance promising therapies for patients, while also helping the organization modernize study oversight through thoughtful adoption of digital and AI-enabled ways of working. Key Duties and Responsibilities: · Partner with project toxicologists and cross-functional stakeholders to develop, review, and operationalize protocols for nonclinical safety assessment studies across both small and large molecule programs. · Serve as a primary monitoring contact for outsourced toxicology and other nonclinical safety studies conducted at CROs and partner organizations. · Conduct routine study monitoring activities through on-site visits and remote oversight to assess study conduct, data quality, protocol compliance, and adherence to GLP and applicable procedures. · Identify, escalate, and help resolve scientific, technical, operational, or study execution issues arising during study conduct in collaboration with CRO personnel, internal toxicologists, and study monitoring colleagues. · Prepare clear, concise, and timely study monitoring reports, visit summaries, and stakeholder communications to ensure visibility to study status, key findings, risks, and next steps. · Drive strong follow-up and documentation of action items, decisions, and study milestones across multiple active studies. · Effectively manage multiple concurrent studies, deliverables, timelines, and follow-up activities in a fast-paced environment while maintaining high quality, attention to detail, and responsiveness. · Contribute to the review of monitoring reports, study documentation, and CRO performance metrics to support continuous improvement in vendor oversight and study execution. · Support qualification activities for CROs, including vendor assessment, audit support, and input into the selection of new external partners. · Collaborate with other study monitor scientists and project toxicologists to support quality review of regulatory documents, submissions, and health authority responses, as applicable. · Demonstrated ability and strong interest in applying digital and AI-based solutions to enhance study planning, study oversight, risk identification, communication, and the sharing of data and knowledge. · Willingness and ability to travel 30%–50% for on-site study monitoring visits and vendor interactions. Knowledge and Skills: Hands-on in vivo laboratory experience in a CRO or pharmaceutical/biotechnology setting. Direct experience supporting nonclinical safety assessment activities involving both small molecule and large molecule modalities. Foundational understanding of the drug discovery and development process, particularly as it relates to nonclinical safety assessment. Working knowledge of Good Laboratory Practice (GLP) regulations and expectations for study conduct and sponsor oversight. Superior organizational and multitasking skills, with the ability to manage multiple concurrent studies, timelines, deliverables, and follow-up activities without losing attention to detail. Strong scientific and problem-solving skills, with the ability to identify issues, assess risk, and support effective resolution during study execution. Excellent interpersonal skills with a demonstrated ability to build productive working relationships with CRO partners, vendors, and internal stakeholders. Excellent written and verbal communication skills, including the ability to communicate complex study information clearly, succinctly, and appropriately for different audiences. Demonstrated ability to thrive in a fast-paced, matrixed environment, successfully adapting to changing priorities while maintaining high-quality execution and clear communication. Strong attention to detail and commitment to high-quality study oversight, documentation, and execution. Comfort adopting new digital tools and technologies, including the exploration and build-out of AI-enabled solutions, to streamline workflows, improve tracking, and support efficient study oversight. Prior experience monitoring outsourced toxicology or nonclinical safety studies in a sponsor-facing study monitoring role. Experience working directly with CROs to oversee study execution, troubleshoot issues, and drive accountability to timelines and deliverables. Demonstrated success in highly organized, detail-oriented roles requiring coordination of multiple concurrent studies and stakeholders. Proven ability to influence and collaborate effectively through strong relationship-building and a proactive, service-oriented approach. Experience using digital tools, dashboards, or AI-assisted technologies to improve planning, documentation, communication, and operational efficiency. Familiarity with regulatory documentation and support for nonclinical sections of submissions. Experience contributing to vendor qualification, audit support, or CRO performance management. Education and Experience: Master’s degree (or equivalent) in life sciences or related science with 3+ years of relevant experience; or Bachelor’s degree (or equivalent) in life sciences or related science with 4+ years of relevant experience. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. Pay Range: $101,600 - $152,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.