Associate Director, Program Toxicologist, Translational Medicine and Nonclinical Development

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

Job summary

BlueRock Therapeutics LP in Cambridge, MA is seeking a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across the pipeline. The role collaborates with program leads and subject-matter experts to advance development.

The position requires a Ph.D. with at least 4 years of toxicology industry experience, experience partnering with CROs, and GLP compliance. Travel to CROs as needed; ensure risk assessments and regulatory submissions support INDs.

Qualifications

• Ph.D. in a relevant field.
• Minimum of 4 years toxicology experience in industry.
• Direct experience partnering with CROs to deliver nonclinical studies.
• Knowledge of cell therapy space is a plus.
• Ability to travel to CRO to oversee study execution.

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 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 interpretation and guidance.
• Develop relationships with CROs and support Toxicology Operations in CRO oversight.
• Ensure GLP compliance and appropriate conduct of studies.
• Travel to CROs to oversee study execution.
• Collaborate with external experts where needed to support program objectives, including pathologists and consultants.
• Review clinical study protocols and author relevant IB/Annual report sections.
• Collaborate on regulatory submissions, including nonclinical sections of IND.
• Share nonclinical strategy within TMND and inform forward-looking plans.
• Prepare written and oral presentations for internal and external dissemination.
• Stay current on evolving regulatory landscape of cell-based therapies.

Education

Ph.D. in relevant field

Job description

Company Overview

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.

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. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

About BlueRock

BlueRock Therapeutics is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and delivering hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

Description of Position

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

Estimated Compensation

The estimated compensation range for this position is $ 174,000.00 - $ 184,950.00 per year.

Equal Opportunity Employment Statement

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.

Artificial Intelligence Statement

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.