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
Estas cookies son necesarias para que el sitio web funcione y no se pueden desactivar en nuestros sistemas. Puede configurar su navegador para bloquear estas cookies, pero entonces algunas partes del sitio web podrían no funcionar.
Seguridad
Experiencia de usuario
Cookies orientadas al público objetivo
Estas cookies son instaladas a través de nuestro sitio web por nuestros socios publicitarios. Estas empresas pueden utilizarlas para elaborar un perfil de sus intereses y mostrarle publicidad relevante en otros lugares.
Google Analytics
Anuncios Google
Utilizamos cookies
🍪
Nuestro sitio web utiliza cookies y tecnologías similares para personalizar el contenido, optimizar la experiencia del usuario e indvidualizar y evaluar la publicidad. Al hacer clic en Aceptar o activar una opción en la configuración de cookies, usted acepta esto.
Los mejores empleos remotos por correo electrónico
¡Únete a más de 5.000 personas que reciben alertas semanales con empleos remotos!