Associate Director, Program Toxicologist, Translational Medicine
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $177,000 - $208,000 per year
Job Level
Senior
About the role
- Design, execute, interpret, and communicate toxicology strategies in support of the BlueRock pipeline from discovery through development.
- Partner with Research, CMC, Device, and other cross-functional teams to ensure strategic alignment around study plans and study design
- Identify safety-related knowledge gaps and propose risk-mitigation plans.
- Ensure preparation of risk assessments, safety summaries, and other technical documents
- Ensure nonclinical studies are executed with a high level of scientific rigor in support Program strategy
- Partner with Toxicology Operations to support study start-up, execution, and timely reporting of results with appropriate interpretation and guidance
- Develop a relationship with CROs and support Toxicology Operations in CRO oversight
- Ensure GLP compliance and appropriate conduct of studies
- Travel to CRO to oversee study execution
- Collaborate with external experts where needed to support program objectives, including but not limited to pathologists and expert consultants
- As needed review clinical study protocols and author relevant IND/IB sections
- Author regulatory submissions and interact with regulatory agencies as needed
- Collaborate within TMND to ensure broad awareness around nonclinical strategy and input into forward looking plans
- Prepare written and oral presentations for internal and external dissemination
- Stay current on the evolving regulatory landscape of cell-based therapies
Requirements
- Ph.D. in relevant field
- Minimum of 4 years toxicology 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 is a plus
- American Board of Toxicology (ABT) certification preferred
- Ability to travel to CRO to oversee study execution
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
toxicologyrisk assessmentstudy designnonclinical studiesGLP complianceregulatory submissionsIND sectionsbiodistributiontumorigenicitylocal tolerability
Soft skills
communicationcollaborationstrategic alignmentrelationship buildingpresentation skillsproblem-solvinginterpersonal skillsleadershiporganizational skillsguidance
Certifications
Ph.D.American Board of Toxicology (ABT)