Associate Director, Toxicology Operations
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $177,000 - $208,800 per year
Job Level
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
toxicology operationsnonclinical study designstudy executionstudy reportingstudy managementbiodistributiontumorigenicitylocal tolerabilitydata archivingsample archiving
Soft Skills
leadershipcollaborationcommunicationrelationship managementorganizational awarenessplanningmonitoringproblem-solvingcross-functional teamworktime management