Toxicology Program Lead - Nonclinical Strategy

Jobtailor; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a PhD-level toxicology leader to design and oversee nonclinical programs across discovery and development. You will partner with cross-functional teams to craft study plans and ensure GLP-compliant execution, while addressing safety knowledge gaps and preparing risk assessments and regulatory documents.

You will manage CRO relationships, travel to sites, and collaborate with external experts to advance cell-based therapies, with a focus on regulatory submissions and

Qualifications

• Ph.D. in a relevant field with industry toxicology experience.
• ABT certification preferred.
• Experience partnering with CROs for nonclinical studies.

Responsibilities

• Design, execute, interpret, and communicate toxicology strategies supporting the pipeline from discovery through development
• Partner with Research, CMC, Device, and other cross-functional teams on study plans and design
• Identify safety-related knowledge gaps and propose risk-mitigation plans
• Ensure preparation of risk assessments, safety summaries, and technical documents
• Ensure scientifically rigorous execution of nonclinical studies
• Support Toxicology Operations with study start-up, execution, and timely reporting of results
• Develop CRO relationships and support CRO oversight
• Ensure GLP compliance and appropriate study conduct
• Travel to CROs to oversee study execution
• Collaborate with external experts, including pathologists and expert consultants
• Review clinical study protocols and author relevant IB/Annual Report sections as needed
• Author regulatory submissions, including nonclinical IND sections, and interact with regulatory agencies
• Collaborate within TMND on nonclinical strategy and forward-looking plans
• Prepare written and oral presentations for internal and external dissemination
• Stay current on the evolving regulatory landscape of cell-based therapies

Skills

Toxicology Strategy Design

GLP Compliance

CRO Partnership

Regulatory Submissions

Communication

Education

Ph.D. in relevant field

Job description

Jobtailor is seeking a PhD-level toxicology leader to design and oversee nonclinical programs across discovery and development. You will partner with cross-functional teams to craft study plans and ensure GLP-compliant execution, while addressing safety knowledge gaps and preparing risk assessments and regulatory documents.

You will manage CRO relationships, travel to sites, and collaborate with external experts to advance cell-based therapies, with a focus on regulatory submissions and