Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
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…