Associate Director, Program Toxicologist, Translational Medicine
About The Position
It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patientsâ 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 BlueRockâs pipeline. The Program Toxicologist will leverage their expertise in toxicology to advance the companyâs development pipeline by working closely with program leads and other subject matter experts. The position will be based in Cambridge, Massachusetts.
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)
- Ability to travel to CRO to oversee study execution
Nice To Haves
- Knowledge of cell therapy space is a plus
- American Board of Toxicology (ABT) certification preferred
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
251-500 employees
