Senior In Vivo Toxicology Lead for IND Programs

Crispr Therapeutics AG; Massachusetts; On-site; USD 160,000 - 180,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

CRISPR Therapeutics seeks an experienced toxicologist to advance IND-enabling pharmacology studies across in vivo programs. Reporting to the Head of in vivo Toxicology, you will drive non-clinical strategy, collaborate with cross-functional teams, and author regulatory sections (IB/IND/CTA).

The role supports licensure and post-approval activities, applying GLP standards and regulatory guidelines. The ideal candidate holds a PhD in toxicology with 8+ years of relevant experience (or a Master’s

Qualifications

• Ph.D. in toxicology or related field with 8+ years of relevant experience, or a Master’s with 15+ years of experience.
• Expertise executing, interpreting, and reporting IND-enabling pharmacology, DMPK, and GLP toxicology studies.
• Experience outsourcing studies to third party CROs and familiarity with GLP standards.
• Experience with IND/CTA, IB, and/or BLA authoring and regulatory interactions.
• Experience working in cross-functional program teams influencing Research, Regulatory, Clinical, and CMC functions.

Responsibilities

• Designs, prepares protocols, and oversees non-clinical non-GLP and GLP studies for product development.
• Directs pharmacology, toxicology, and DMPK activities from in vivo work through IND-enabling stages.
• Authors non-clinical sections for regulatory filings (IB/IND/CTA/briefing books).
• Reviews and integrates nonclinical datasets for project teams and leadership.
• Collaborates with research and clinical development to interpret findings and mitigate issues.

Skills

IND enabler pharmacology

DMPK studies

GLP toxicology

CRO management

Regulatory writing

Cross-functional collaboration

Scientific communication

Education

PhD in toxicology

Master's in toxicology

Job description

CRISPR Therapeutics seeks an experienced toxicologist to advance IND-enabling pharmacology studies across in vivo programs. Reporting to the Head of in vivo Toxicology, you will drive non-clinical strategy, collaborate with cross-functional teams, and author regulatory sections (IB/IND/CTA).

The role supports licensure and post-approval activities, applying GLP standards and regulatory guidelines. The ideal candidate holds a PhD in toxicology with 8+ years of relevant experience (or a Master’s