Clinical Quality Associate Jobs in Woonsocket, RI

Job Description:

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis 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 Therapeuticsis 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 Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco,California.

Position Summary

CRISPR Therapeutics is searching for an Associate Director, Clinical Scientist to provide scientific input for early and late stage clinical development programs.

Responsibilities

• Contribute to the scientific development of clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
• Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
• Significantly contribute to the oversight of the clinical study in collaboration with the clinical development lead
• Present data and information to investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities
• Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
• Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
• Support study execution as the scientific subject matter expert
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy
• Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
• Support preparation of scientific material for conference presentations or publications
• Contribute to the authoring and revision of regulatory submissions
• Perform analyses and generate scientific slide decks based on clinical, translational and other datasets
• Provide mentorship to junior clinical scientists

Minimum Qualifications

• Advanced scientific or clinical degree (eg MD, PhD, PharmD, DNP, MSN , etc). with 8-12+ years of relevant experience in clinical or related research
• Excellent oral and written communication skills and analytical skills
• Deep expertise in clinical science, with a strong track record of contributing to clinical studies
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP)
• Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

Preferred Qualifications

• Experience in cellular therapies/CAR-T trials
• Experience in Phase 1/Phase 2 clinical trials

Competencies

• Collaborative - Openness, one team, positivity
• Undaunted - Fearless, can-do attitude, self-starter
• Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical
• Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box

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, Clinical Scientist: Base pay range of $170,000 to $185,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

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