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
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., biodistribution, tumorigenicity, local tolerability)
Knowledge of cell therapy space is a plus
American Board of Toxicology (ABT) certification preferred
Ability to travel to CRO to oversee study execution
Diese Cookies sind für das Funktionieren der Website erforderlich und können in unseren Systemen nicht abgeschaltet werden. Sie können Ihren Browser so einstellen, dass er diese Cookies blockiert, aber dann könnten einige Teile der Website nicht funktionieren.
Sicherheit
Benutzererfahrung
Zielgruppenorientierte Cookies
Diese Cookies werden über unsere Website von unseren Werbepartnern gesetzt. Sie können von diesen Unternehmen verwendet werden, um ein Profil Ihrer Interessen zu erstellen und Ihnen an anderer Stelle relevante Werbung zu zeigen.
Google Analytics
Google Ads
Wir benutzen Cookies
🍪
Unsere Website verwendet Cookies und ähnliche Technologien, um Inhalte zu personalisieren, das Nutzererlebnis zu optimieren und Werbung zu indvidualisieren und auszuwerten. Indem Sie auf Okay klicken oder eine Option in den Cookie-Einstellungen aktivieren, stimmen Sie dem zu.
Die besten Remote-Jobs per E-Mail
Schliess dich über 5'000+ Personen an, die wöchentlich Benachrichtigungen über Remote-Jobs erhalten!