Senior Program Toxicologist - Nonclinical Strategy

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

Job summary

BlueRock Therapeutics, a Bayer subsidiary in Cambridge, MA, seeks a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across discovery to development and advance the company’s pipeline.

The role partners with program leads and cross-functional teams to design, interpret, and communicate toxicology strategies, ensuring GLP compliance and timely CRO oversight. Based in Cambridge, MA, this position combines scientific rigor with regulatory collaboration.

Qualifications

• Ph.D. in a relevant field.
• Minimum of 4 years of toxicology experience in industry.
• Direct experience partnering with CROs to deliver nonclinical studies (toxicology, biodistribution, tumorigenicity, local tolerability).
• Knowledge of cell therapy space is a plus.

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 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 IB/Annual report sections.
• Author regulatory submissions, including nonclinical sections of IND, 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

Skills

Toxicology expertise

CRO partnership

Regulatory submissions

Stakeholder communication

Education

Ph.D. in relevant field

ABT certification preferred

Job description

BlueRock Therapeutics, a Bayer subsidiary in Cambridge, MA, seeks a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across discovery to development and advance the company’s pipeline.

The role partners with program leads and cross-functional teams to design, interpret, and communicate toxicology strategies, ensuring GLP compliance and timely CRO oversight. Based in Cambridge, MA, this position combines scientific rigor with regulatory collaboration.