Senior Program Nurse Manager - Cell Engineering & Therapy

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Senior Program Nurse Manager will provide leadership and direction for the Clinical Research Operations of the Columbia Initiative in Cell Engineering and Therapy (CICET). This role will work closely with Clinical Regulatory Affairs and Compliance to ensure the effective planning, execution, and oversight of both sponsored and investigator-initiated clinical trials.

The Senior Program Nurse Manager will report to the Associate Director of Programs Management and, for clinical matters, work under the supervision of the Director for Translational Research, Cell Therapy, and Bone Marrow Transplant Program.

Responsibilities

Clinical Research Operations Management

• Oversee the Columbia Institute of Cell Engineering and Therapy (CICET) Clinical Research Operations Team.
• Collaborate with CICET leadership to create and harmonize workflows and develop and promote a structure that creates efficient and streamlined clinical operations processes.
• Work collaboratively with the Cell Therapy Service Medical Director, Clinical Study Principal Investigators, CICET GMP Medical Director, Clinical Protocol and Data Management (CPDM) Team, and other stakeholders to ensure compliant conduct of research protocols.
• Support clinical study participant management, including screening and eligibility determination.
• Support the clinical principal investigator on protocol-related nursing care of the study participants, including tracking contraindicated medications, adverse events, and clinical laboratory testing.
• Develop clinical research SOPs for new workflows and processes.
• Effectively communicate risks and unresolved issues to CICET and CPDM leadership and across the organization.
• Generate quarterly reports for cell therapy trial activity for the CICET quality meeting.

Clinical Regulatory Affairs and Compliance

• Support the CICET's leadership to achieve clinical development goals.
• Support the Clinical Protocol review and approval process in a timely manner.
• Oversee all tasks associated with the regulatory management of research protocols.
• Oversee that all regulatory documents, data, and files are up to date.
• Oversee study feasibility and study start-up for research protocols.
• Ensure all manufacturing processes comply with FDA, GMP, FACT, and other regulatory standards.
• Coordinate with the Clinical Trials Office for CMC, investigator manuals, and IND development and submission.
• Participate in regulatory audits and inspections of the GMP laboratory, coordinating with the QA Director, sponsors, and appropriate stakeholders.
• Participate in site audits and monitoring visits for research studies under CICET, coordinating with cell lab, apheresis, disease teams, sponsors, and appropriate stakeholders.
• Contribute to regulatory submissions and maintain robust documentation and evaluation metrics for all manufacturing activities.

Personnel Management

• Manage and lead nursing staff as well as serve as a role model and other teams working on clinical studies.
• Assigns and manages weekly schedules, time, and attendance.
• Ensures that the status of licenses, certifications, and any required competencies is current and completed by required deadlines.
• Manage and evaluate employees' orientation and ongoing training.

Clinical Responsibility

• Collaborate with CICET groups, stakeholders, and vendors to integrate new technologies and processes into manufacturing.
• Coordinate cross-functional teams to meet production timelines, interfacing with QA / QC teams.

Minimum Qualifications

• Bachelor's degree in nursing, or equivalent in education.
• Minimum of 5 years of experience in managing sponsored and investigator-initiated clinical studies in cell and gene therapies.
• Proven track record of managing clinical research operations.
• Strong leadership skills with experience in team management and development.

Preferred Qualifications

• Strongly prefer at least 7 years of experience in cell therapy manufacturing
• Advanced degree (MS or PhD) in a relevant scientific discipline
• Preferably 8 years of experience with cell and gene therapy clinical research
• Experience in developing clinical trial designs and clinical research protocols
• Experience in preparing and managing Investigational New Drug Applications for Phase 1 and 2

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.