Oncology NCI Research Cell Therapy - Assistant Director

J. Morrissey

Full-time - Mid Level

Administrative and Support Services

About the position

The Assistant Director for Therapeutic Clinical Research will oversee the operations of human clinical trials supporting various oncology disease research groups funded by NCTN and NCI. This role involves strategic collaboration with a team to enhance productivity, compliance, and protocol adherence for Phase I cancer cell therapies. The Assistant Director will provide leadership, education, and resources to clinical research managers and staff, ensuring effective operations and adherence to Good Clinical Practices.

Responsibilities

• Oversee human clinical trial operation staff and operations for oncology disease research groups.
• Strategize with a collaborative team on objectives related to productivity, compliance, and protocol adherence.
• Delegate and emphasize strategic initiatives for clinical trials.
• Establish priorities and timelines for efficient operations.
• Provide education and resources to staff, peers, and oncology team leaders.
• Develop collaboration with affiliated hospital staff for trial patient treatments.
• Guide teams towards effective operational and SOP recommendations.
• Review KPIs and create regular reports for data management.
• Utilize data to monitor protocol activation processes.
• Communicate data trends and collaborate with sponsors.
• Ensure timely performance of disease team portfolio from protocol concept to open accrual status.

Requirements

• Master's Degree (preferred) or minimum Bachelor degree.
• 8 years of human clinical research experience, including clinical trials research operations.
• Minimum of 3 years of people management experience within the 8 years.
• Advanced knowledge of clinical trials, regulatory processes, and study life cycles.
• Prior academic or industry background in Clinical Trials and/or Research preferred.
• Oncology disease background and experience highly preferred.
• Good Clinical Practice certification or willingness to obtain within one year.
• Experience with conducting periodic reviews of clinical trial portfolios.
• Knowledge of immune cell therapy preferred.
• Experience coordinating audits of systems and practices.
• Data management experience for protocol activation and regulatory compliance.
• Strong communication, leadership, and team-building skills.
• Effective problem-solving and resource management skills.
• Ability to work in a fast-paced environment and resolve conflicts.

Nice-to-haves

• Experience with MS Word, Excel, RAVE, ONCore, Redcap.

Benefits

• Relocation stipend available.
• Competitive hourly pay based on experience.