Associate Director, In Vivo Toxicology & IND Strategy

Crispr Therapeutics AG; Boston (MA); Hybrid; USD 160,000 - 180,000; Full time

Job summary

CRISPR Therapeutics 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 acts as a SME across toxicology, pharmacology, and DMPK to drive nonclinical strategy.

Responsibilities include designing and overseeing GLP and non-GLP studies, ensuring QA standards, coordinating with stakeholders, and contributing to regulatory filings and development plans.

Qualifications

• Ph.D. in toxicology or related field with 8+ years of relevant experience, or a Master’s with 15+ years of relevant experience.
• Experience executing IND-enabling pharmacology, DMPK, and/or GLP toxicology studies.
• Experience outsourcing studies to CROs and familiarity with GLP standards.
• Experience with IND/CTA, IB, and/or BLA authoring and regulatory interactions.

Responsibilities

• Designs non-clinical pharmacology studies to support development.
• Directs pharmacology, toxicology, and DMPK activities from in vivo studies to FIH evaluation.
• Ensures studies meet FDA, CHMP, WHO, GLP, and ISO standards.
• Collaborates with research and clinical teams on non-standard studies.
• Authors non-clinical sections for regulatory filings (IB, IND, etc.).
• Reviews and integrates complex datasets across nonclinical disciplines.

Skills

Communication skills

Independent work

Problem solving

Regulatory writing

Education

Ph.D. in toxicology or related field

Master’s in toxicology or related field with 15+ years of experience

Job description

CRISPR Therapeutics 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 acts as a SME across toxicology, pharmacology, and DMPK to drive nonclinical strategy.

Responsibilities include designing and overseeing GLP and non-GLP studies, ensuring QA standards, coordinating with stakeholders, and contributing to regulatory filings and development plans.