Manager, Infusion Support Operations

Company Overview

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 Bayer and 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.

Position Summary

Reporting to the Executive Director, Clinical Development, the Manager, Infusion Support Operations will be responsible for providing technical and clinical support both internally and externally during clinical trials and other infusion related activities. This role will work on cross-functional study teams for the execution of clinical trial activities, data interpretation, and communication across all company activities as needed. This individual will interface directly with other functions including Clinical Operations, Technical Operations, Quality, Regulatory Affairs.

The Manager, Infusion Support Operations will not work in a clinical care role providing direct patient care. The Manager, Infusion Support Operations will be available to provide training, support, and education to various members of the clinical trial site team including but not limited to the stem cell laboratory personnel, the cell therapy transplant team, and clinical research team on CRISPR drug product handling, storage, administration, and monitoring.

Responsibilities

• Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material to support clinical trials. Develop infusion and protocol training materials to support internal and external activities
• Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, medical affairs, regulatory affairs, healthy donor program, etc) to ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of shared process improvement programs
• Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing
• Train clinical sites on receipt, storage, thaw, and infusion procedures related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol
• Assesses and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial
• Participate in study site selection by evaluating a site’s ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures
• Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays)
• Serve as apheresis SME during onboarding, routine oversight, and audits of apheresis collection vendors
• Provide apheresis SME support to the cross-functional team delivering high-quality apheresis starting material to GMP manufacturing of IO CART products.
• Works with cross-functional team to identify opportunities to improve apheresis product, as needed by GMP manufacturing. This may include updates to the vendor procedures or processes and supporting change documentation by CRISPR.
• Support correlative analyses of apheresis products with donor characteristics, manufacturing success, and clinical outcomes.

Minimum Qualifications

• Advanced degree in a scientific discipline such as
  • RN and 5-7+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
  • Pharm D or PhD 1-3+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
• Excellent oral and written communication skills
• Experience working with MS PowerPoint, MS Word, MS Excel, Teams and SharePoint as well as Zoom video conferencing
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• A thorough understanding of ICH, GCP, GDP and relevant regulatory requirements
• 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 with infusion procedures
• Experience with clinical education

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.