Associate Director, Program Toxicologist, Translational Medicine

Who is BlueRock? BlueRock 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. What Are We Doing? 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. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives.

Description of Position : It continues to be an exciting time for BlueRock 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 BlueRock'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.

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 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

Minimum Requirements