Lead Program Toxicologist – Cell Therapy & Regulatory

BlueRock Therapeutics LP; Cambridge (MA); On-site; USD 174,000 - 185,000; Full time

Job summary

BlueRock Therapeutics LP in Cambridge, MA is seeking a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across the pipeline. The role collaborates with program leads and subject-matter experts to advance development.

The position requires a Ph.D. with at least 4 years of toxicology industry experience, experience partnering with CROs, and GLP compliance. Travel to CROs as needed; ensure risk assessments and regulatory submissions support INDs.

Qualifications

• Ph.D. in a relevant field.
• Minimum of 4 years toxicology experience in industry.
• Direct experience partnering with CROs to deliver nonclinical studies.
• Knowledge of cell therapy space is a plus.
• Ability to travel to CRO to oversee study execution.

Responsibilities

• 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 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 of program strategy.
• Partner with Toxicology Operations to support study start-up, execution, and timely reporting of results with interpretation and guidance.
• Develop relationships with CROs and support Toxicology Operations in CRO oversight.
• Ensure GLP compliance and appropriate conduct of studies.
• Travel to CROs to oversee study execution.
• Collaborate with external experts where needed to support program objectives, including pathologists and consultants.
• Review clinical study protocols and author relevant IB/Annual report sections.
• Collaborate on regulatory submissions, including nonclinical sections of IND.
• Share nonclinical strategy within TMND and inform forward-looking plans.
• Prepare written and oral presentations for internal and external dissemination.
• Stay current on evolving regulatory landscape of cell-based therapies.

Education

Ph.D. in relevant field

Job description

BlueRock Therapeutics LP in Cambridge, MA is seeking a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across the pipeline. The role collaborates with program leads and subject-matter experts to advance development.

The position requires a Ph.D. with at least 4 years of toxicology industry experience, experience partnering with CROs, and GLP compliance. Travel to CROs as needed; ensure risk assessments and regulatory submissions support INDs.