Associate Director, Program Toxicologist, Translational Medicine and Nonclinical Development

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing the proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease.

About the role

BlueRock Therapeutics is advancing cutting-edge cellular therapies to positively impact patients’ lives across multiple disease areas. The Program Toxicologist will take on a highly visible role with internal and external stakeholders, providing scientific and strategic leadership for nonclinical studies in support of BlueRock’s pipeline. This position will be based in Cambridge, Massachusetts.

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 of program strategy.
• Partner with Toxicology Operations to support study start-up, execution, and timely reporting of results with appropriate interpretation and guidance.
• Develop relationships 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.
• Review clinical study protocols and author relevant IB/Annual report sections as needed.
• Author regulatory submissions, including nonclinical sections of IND, and interact with regulatory agencies as needed.
• Collaborate within Translational Medicine and Nonclinical Development (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 a relevant field.
• Minimum of 4 years of toxicology experience in industry.
• Must have direct experience partnering with CROs to deliver nonclinical studies (e.g., toxicology, biodistribution, tumorigenicity, local tolerability).
• Knowledge of the cell therapy space is a plus.
• Neurology and/or ophthalmology experience is a plus.
• American Board of Toxicology (ABT) certification preferred.
• Ability to travel to CRO to oversee study execution.

Pay

The estimated compensation range for this position is up to $450,000.00 per year.