Associate Director, in vivo Toxicology

Position Summary

Crispr

Therapeutics seeks an experienced toxicologist to advance IND-enabling pharmacology studies for our in vivo programs. Reporting to the Director, Head of in vivo Toxicology the position will work cross functionally as a toxicology, pharmacology, and DMPK subject matter expert to drive our in vivo nonclinical strategy forward.

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
• Review, summarize, and integrate complex datasets across all nonclinical disciplines for project teams, senior leaders, internal/external partners and/or scientific groups.

Minimum Qualifications

• Ph.D. in toxicology or related field with 8+ years of relevant experience, or a non-PhD, 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.
• Experience with IND/CTA, IB, and/or BLA authoring and regulatory interactions (pre-IND/pre-CTA, EOP meetings, etc.).
• Experience working in cross-functional program teams influencing Research, Regulatory, Clinical, and CMC functions.
• Scientifically rigorous and highly organized, with significant attention to detail
• Excellent oral and written communication skills
• Self-driven and independently motivated
• Exceptional problem-solving ability
• Ability to work independently and to collaborate with peers across various functions

Preferred Qualifications

• Experience with gene therapy, cardiovascular and/or rare disease therapeutic areas
• Familiarity with mRNA/LNP delivery and platform technology, siRNAs, cell therapy, or biotechnology drug products

Competencies

• Collaborative - Openness, One Team
• Undaunted - Fearless, Can-do attitude
• Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit - Proactive. Ownership mindset.

Crispr

Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Pay and benefits

Associate Director: Base pay range of $160,000 to $180,000+ bonus, equity and benefits