Associate Director, Toxicology Operations

Role Overview

• Support Program Toxicologists in the design of nonclinical studies
• Lead Nonclinical Study Team(s) for multiple studies and assets
• Lead nonclinical study start-up, execution, and timely reporting of results and ensure organizational awareness around study progress
• Partner with CRO to plan and manage study timelines
• Act as the internal lead to ensure smooth transfer of study materials to CRO in support of study plans
• Partner with Research, CMC, Device, and other cross-functional teams to ensure awareness around study timelines, upcoming milestones, and study reporting
• Manage all associated tasks in the planning, initiation, monitoring, and compliance of nonclinical studies
• Develop a relationship with key leaders at CRO, including Study Directors and Business Development
• Travel regularly to CRO to oversee study execution
• Travel to audit CROs/labs as needed
• Ensure raw data and study reports are archived appropriately
• Ensure clinical and nonclinical samples are archived appropriately
• Collaborate within TMND to ensure broad awareness around nonclinical strategy and input into forward looking plans

Requirements

• BS or MS in relevant field
• Minimum of 6 years toxicology operations experience in industry
• Must have direct experience partnering with CROs to deliver nonclinical studies (e.g., biodistribution, tumorigenicity, local tolerability)
• Knowledge of cell therapy space preferred
• Ability to travel

Benefits

• Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity.