Associate Director, in vivo Toxicology

Crispr Therapeutics Inc in; Boston (MA); Hybrid; USD 160,000 - 180,000; Full time

Job summary

CRISPR Therapeutics, Inc. seeks an experienced toxicologist to advance IND-enabling pharmacology studies for in vivo programs.

The role reports to the Director, Head of in vivo Toxicology and acts as a cross-functional SME across toxicology, pharmacology and DMPK to drive nonclinical strategy. Remote work is allowed with a minimum on-site presence; associated duties include collaboration across teams, authoring non-clinical sections for regulatory filings, and supporting early development

Qualifications

• Ph.D. in toxicology or related field with 8+ years of relevant experience.
• Master’s in toxicology or related field with 15+ years of relevant experience is acceptable.

Responsibilities

• Designs non-clinical non-GLP and GLP studies; prepares protocols and supervises studies.
• Supports resourcing for pharmacology, toxicology, and DMPK activities from in vivo studies to IND/LICENSURE.
• Ensures studies meet FDA/CHMP/WHO/GLP/ISO standards and guidelines.

Skills

IND experience

GLP toxicology

DMPK

CRO outsourcing

Regulatory interactions

Education

PhD toxicology

Master's toxicology

Tools

IB/IND documents

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 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.

Remote Work

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.

Associate Director: Base pay range

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

Equal Employment Opportunity

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Company Repetition

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies 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, and business offices in London, United Kingdom. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy