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Job description
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 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, BlueRock 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.
What Are We Doing?
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.
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.
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 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
Minimum Requirements
Ph.D. in relevant field
Minimum of 4 years toxicology experience in industry
Must have direct experience partnering with CROs to deliver nonclinical studies (e.g., toxicology, biodistribution, tumorigenicity, local tolerability)
Knowledge of 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
The estimated compensation range for this position is $ 174,000.00 - $ 184,950.00 per year.
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.