BlueRock Therapeutics · 1 month ago
Associate Director, Program Toxicologist, Translational Medicine
Cambridge, Massachusetts
Full-time
Hybrid
Lead/Staff, Director/Executive
$177K/yr - $208K/yr
4+ years expBlueRock Therapeutics is a leading engineered cell therapy company focused on creating cellular medicines for various diseases. The Program Toxicologist will provide scientific and strategic leadership for nonclinical studies, collaborating with cross-functional teams to advance the company's development pipeline.
BiopharmaBiotechnologyHealth CareMedical
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
Qualification
Required
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
Ability to travel to CRO to oversee study execution
Preferred
American Board of Toxicology (ABT) certification preferred
Company
BlueRock Therapeutics
It is a regenerative medicine company.
201-500 employees
H1B Sponsorship
BlueRock Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (5)
2022 (3)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$225M2019-08-08Acquired
2016-12-12Series A· $225M
Leadership Team
Seth Ettenberg
President and CEO
Stefan Irion
Chief Scientific Officer
Recent News
2025-12-02
Company data provided by crunchbase