In Vivo Toxicology: Associate Director, IND-Enabling

CRISPR Therapeutics, Inc.; Boston (MA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Bonus and equity

Job summary

CRISPR Therapeutics, Inc. in Boston seeks an experienced toxicologist to advance IND-enabling pharmacology studies for in vivo programs. The role reports to the Director, Head of in vivo Toxicology and works across toxicology, pharmacology, and DMPK to drive nonclinical strategy forward.

The candidate will design and oversee non-clinical studies, ensure GLP compliance, and contribute to regulatory filings. This position supports FIH evaluation and develops strategies across development stages.

Qualifications

• Ph.D. in toxicology or related field with 8+ years of relevant experience, or a Master’s in toxicology or related field with 15+ years of relevant experience.
• Expertise executing, interpreting, and reporting IND-enabling pharmacology, DMPK, and/or GLP toxicology studies.
• Experience outsourcing studies to third party CROs and familiarity with GLP standards.

Responsibilities

• Designs, prepares protocols for, ensures appropriate resourcing for, monitors, and reviews reports for non-clinical non-GLP and GLP studies performed internally and at external vendors to support product development.
• Supports the appropriate resourcing for, and directs pharmacology, toxicology, and DMPK activities beginning with in vivo studies to support initial first in human (FIH) evaluation and throughout the development process, including licensure and post approval.
• Ensures that studies and assay sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO).
• Collaborates with research and clinical development on investigational or non-standard studies to understand and mitigate any adverse observations.
• Designs and perform investigative or non-standard toxicology studies to inform on mechanism of action.
• Serves as functional line representative on multiple project development teams in various therapeutic areas.
• Develop non-clinical strategies and provide expert support to development projects, including potential impact of non-clinical results on program and clinical/regulatory strategies.
• Authors non-clinical sections for documents to support regulatory filings (e.g., IB, IND, CTA, briefing books, regulatory query responses).
• Collaborates with employees across various functions, sharing information and expertise.

Skills

IND-enabling pharmacology

DMPK

GLP toxicology

Cross-functional collaboration

Regulatory interactions

Education

Ph.D. in toxicology

Master’s in toxicology (optional)

Job description

CRISPR Therapeutics, Inc. in Boston seeks an experienced toxicologist to advance IND-enabling pharmacology studies for in vivo programs. The role reports to the Director, Head of in vivo Toxicology and works across toxicology, pharmacology, and DMPK to drive nonclinical strategy forward.

The candidate will design and oversee non-clinical studies, ensure GLP compliance, and contribute to regulatory filings. This position supports FIH evaluation and develops strategies across development stages.