Strategic Associate Director, In Vivo Toxicology

Crispr Therapeutics AG

Boston (MA)

On-site

USD 160,000 - 180,000

Full time

8 days ago

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Job summary

CRISPR Therapeutics seeks an Associate Director of in vivo Toxicology to advance IND-enabling pharmacology for in vivo programs at the South Boston site. The role reports to the Director of in vivo Toxicology and works cross-functionally to drive nonclinical strategy forward, supporting FIH evaluation and ongoing development.

The candidate will design non-clinical studies, ensure GLP compliance, and author regulatory sections.

Qualifications

Ph.D. in toxicology with 8+ years (or MS with 15+ years) of relevant 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.

Responsibilities

Designs, prepares protocols for non-clinical studies and ensures resourcing and monitoring.
Supports pharmacology, toxicology, and DMPK activities from in vivo studies through licensure.
Ensures studies meet quality and regulatory standards (FDA, CHMP, WHO, GLP, ISO).
Collaborates with research and clinical development on non-standard studies.
Authors non-clinical sections for regulatory filings (IB, IND, CTA, briefing books).
Reviews and integrates complex datasets across nonclinical disciplines for project teams.