Associate Director, in vivo Toxicology

CRISPR Therapeutics•Boston, MA

1d•$160,000 - $180,000•Hybrid

About The Position

CRISPR Therapeutics seeks an experienced toxicologist to advance IND-enabling pharmacology studies for its in vivo programs. Reporting to the Director, Head of in vivo Toxicology, this position works cross-functionally as a toxicology, pharmacology, and DMPK subject matter expert to advance the company’s in vivo nonclinical strategy. The role supports product development from initial first-in-human evaluation through development, licensure, and post-approval. It involves directing and overseeing nonclinical studies, developing nonclinical strategies, contributing expertise to project teams, and preparing nonclinical sections of regulatory documents. The position collaborates with research, clinical development, regulatory, and other functions, and reviews and integrates complex nonclinical datasets.

Requirements

Ph.D. in toxicology or a related field with 8 or more years of relevant experience, or a Master's degree in toxicology or a related field with 15 or more years of relevant experience for non-Ph.D. candidates.
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 authoring IND/CTA, IB, and/or BLA documents and participating in regulatory interactions, such as pre-IND/pre-CTA and EOP meetings.
Experience working in cross-functional program teams and influencing Research, Regulatory, Clinical, and CMC functions.
Scientific rigor, strong organization, and significant attention to detail.
Excellent oral and written communication skills.
Self-driven and independently motivated.
Exceptional problem-solving ability.
Ability to work independently and collaborate with peers across functions.

Nice To Haves

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

Responsibilities

Design, prepare protocols for, resource, monitor, and review reports for internal and external nonclinical non-GLP and GLP studies supporting product development.
Support resourcing for and direct pharmacology, toxicology, and DMPK activities, from in vivo studies supporting initial first-in-human evaluation through development, licensure, and post-approval.
Ensure studies and assay sample analyses follow applicable quality and regulatory standards and guidelines, including FDA, CHMP, WHO, GLP, and ISO.
Collaborate with research and clinical development on investigational or non-standard studies to understand and mitigate adverse observations.
Design and perform investigative or non-standard toxicology studies to inform mechanism of action.
Serve as the functional line representative on multiple project development teams across therapeutic areas.
Develop nonclinical strategies and provide expert support to development projects, including assessing potential effects of nonclinical results on program and clinical or regulatory strategies.
Author nonclinical sections of regulatory documents, including IBs, INDs, CTAs, briefing books, and regulatory query responses.
Collaborate with employees across functions, sharing information and expertise.
Review, summarize, and integrate complex datasets across nonclinical disciplines for project teams, senior leaders, internal and external partners, and scientific groups.