Research Associate, Non-Clinical Toxicology

What You’ll Do: We are seeking a highly organized and motivated Research Associate, Non-Clinical Toxicology to support the oversight and operational execution of our outsourced nonclinical studies. This role will assist with the coordination and monitoring of toxicology, pharmacology, and biodistribution studies conducted at contract research organizations (CROs) in support of regulatory submissions and pipeline advancement.

The ideal candidate will have foundational knowledge of nonclinical drug development, strong project coordination skills, and the ability to manage multiple studies in a dynamic biotech environment.

Responsibilities:

• 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

Qualifications:

• 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.