Director of Toxicology - IND-Enabling Biotech Leader

Stealth Co; Cambridge (MA); Hybrid; USD 230,000 - 360,000; Full time

Benefits offered by this job

Competitive compensation

Growth opportunities

Investor backing

Job summary

Stealth Co in Cambridge, MA is seeking a Director/Senior Director to lead nonclinical toxicology, including GLP studies and IND-enabling work, partnering with CROs and internal teams in a fast-paced biotech startup.

This role shapes the toxicology strategy for biologics programs, ensures GLP compliance and regulatory readiness, and contributes to human dose selection and regulatory submissions in collaboration with regulatory and clinical teams.

Qualifications

• PhD, DVM, or equivalent advanced degree in toxicology or related field.
• 10+ years of industry experience preferred.
• Experience leading GLP toxicology and IND-enabling programs.
• Experience developing toxicology strategy for biologics programs.

Responsibilities

• Lead development and execution of nonclinical toxicology strategies supporting candidate selection, GLP toxicology, IND-enabling activities, and first-in-human studies.
• Design and oversee non-GLP and GLP toxicology studies, including dose range-finding, repeat-dose, recovery, and other studies as appropriate for the development program.
• Partner with internal teams and external CROs to develop study designs, protocols, dosing strategies, endpoints, timelines, and data analysis plans.
• Serve as the primary scientific point of contact for external toxicology CROs, overseeing study design, study execution, data review, issue resolution, and delivery of high-quality study reports.
• Interpret toxicology, clinical pathology, histopathology, and other nonclinical data to identify potential target organ toxicities, exposure-response relationships, safety margins, and other development risks.
• Integrate toxicology findings with pharmacology, PK/PD, bioanalytical, CMC, and clinical development data to inform candidate selection, human dose selection, and overall development strategy.
• Support preparation and review of IND-enabling documentation, including nonclinical study reports, investigator materials, regulatory briefing documents, and IND submissions.
• Collaborate with regulatory and clinical teams to develop nonclinical sections of regulatory submissions and support interactions with regulatory agencies.
• Establish and maintain appropriate toxicology plans, timelines, budgets, and key milestones across development programs.
• Maintain detailed records, perform data analysis, and clearly communicate toxicology findings and recommendations to cross-functional teams and company leadership.
• Ensure toxicology activities are conducted in accordance with applicable GLP, animal welfare, quality, and regulatory standards.

Skills

Toxicology leadership

GLP toxicology

IND submissions

Biologics understanding

Regulatory coordination

Education

PhD/VDM-equivalent

Job description

Stealth Co in Cambridge, MA is seeking a Director/Senior Director to lead nonclinical toxicology, including GLP studies and IND-enabling work, partnering with CROs and internal teams in a fast-paced biotech startup.

This role shapes the toxicology strategy for biologics programs, ensures GLP compliance and regulatory readiness, and contributes to human dose selection and regulatory submissions in collaboration with regulatory and clinical teams.