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.