Associate Director, Program Toxicologist, Translational Medicine and Nonclinical Development

Blue Rock 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 our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016, Blue Rock is at the forefront of the convergence of cell biology and genetic engineering. 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 and offer hope to millions of patients worldwide.

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.

We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

Blue Rock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique CELL+GENE™ platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel CELL+GENE™ platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

It continues to be an exciting time for Blue Rock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients’ lives across multiple disease areas.

The Program Toxicologist will be expected to take on a highly visible role with internal and external stakeholders through providing scientific and strategic leadership for nonclinical studies in support of Blue Rock’s pipeline. The Program Toxicologist will leverage their expertise in toxicology to advance the company’s development pipeline by working closely with program leads and other subject matter experts. The position will be based in Cambridge, Massachusetts.

• Design, execute, interpret, and communicate toxicology strategies in support of the Blue Rock 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…