Research Associate, Non-Clinical Toxicology

• →Manage contract workflows with nonclinical vendors including CROs
• →Cross-collaboration with accounting to manage accruals

• →Support the management and oversight of outsourced nonclinical studies including: GLP and non-GLP toxicology studies, Safety pharmacology studies, PK/PD and biodistribution studies, exploratory pharmacology studies
• →Assist program toxicologists and scientific leads with study planning, timelines, budgets, and deliverables
• →Track study progress, milestones, sample shipments, and data transfers
• →Participate in study-related meetings with CROs and internal cross-functional teams
• →Review study documentation including protocols, amendments, data tables, draft reports, and study records for accuracy and completeness
• →Maintain study trackers and vendor files in compliance with internal procedures and regulatory expectations
• →Coordinate sample management and logistics across internal and external laboratories
• →Support audit and inspection readiness activities
• →Identify operational issues proactively and escalate risks or delays appropriately
• →Contribute to SOP development and process improvement initiatives within nonclinical operations

• Bachelor’s degree in Toxicology, Biology, Pharmacology, Life Sciences, or related discipline
• 2+ years of experience in biotech, pharmaceutical, CRO, or academic research environments
• Prior experience supporting outsourced nonclinical or preclinical studies preferred
• Familiarity with nonclinical drug development and regulatory expectations supporting IND-enabling studies
• Understanding of GLP principles and CRO study conduct preferred
• Strong organizational and project coordination skills
• Experience with study tracking systems or document management systems is a plus
• Proficiency in Microsoft Office, especially Excel and PowerPoint

Location: This is a hybrid position with three days on site at our office in Burlington, MA.

Travel: Minimal travel is expected for this position.