Head of Investigator Initiated Trials Unit

Job overview

An exciting and unique opportunity has arisen to lead our Investigator-Initiated Trials (IIT) Team. This Head of IIT role will shape strategy, oversee a diverse portfolio of academic, early phase oncology clinical trials, and collaborate with world-leading researchers, industry and academic collaborators and various governance committees. The ideal candidate will bring deep expertise in clinical research, a strong leadership presence, and a passion for patient-centred academic clinical trials. With a focus on advancing hypothesis driven, biomarker enriched clinical trials through academic research, this position offers an excellent opportunity for those looking to make a significant impact in drug development.

Main duties of the job

The post holder will be educated to at least degree level in life sciences or a health-related field, with demonstrable experience in leading a team and working in clinical trials. They must have an excellent understanding of the conduct of Phase I oncology trials, demonstrable people management skills, strong communication skills to effectively engage with collaborators, including investigators, sponsors and regulatory bodies. The post holder must be highly organised and able to plan work around a busy clinical unit.

Detailed job description and main responsibilities

For further information, please refer to the job description and person specification

Strategic Leadership

Develop a portfolio of transformational trials by engaging with Investigators in alignment with organizational strategies and available funding streams.

Develop the DDU-IIT team, maintaining a core team of expert staff and building up longer-term viability of capacity for project management and monitoring.

Provide a strategic vision for the DDU-IIT team to complement ICR/RM strategy and business plan, ensuring performance is in line with organisational requirements.

Contribute to the overall leadership of the DDU by playing an active role in the senior management team, deputising for the Head of Operations when absent.

Operational Leadership

Lead the execution of investigator-initiated trials, ensuring the integration of digital systems for realtime data tracking, compliance monitoring, and risk assessment.

Oversee and direct clinical research operations to ensure studies are conducted to the highest standards and in compliance with ICH-GCP and UK legislation.

Oversee the management of investigator-initiated trials, ensuring systems are established to monitor all aspects of study progress, including screening, recruitment, compliance, IMP management, pharmacovigilance and reporting.

Oversee the development and use of electronic regulatory documentation and digital pharmacovigilance systems to enhance reporting accuracy and compliance

Prepare or oversee preparation of clinical study protocols in conjunction with Chief Investigator and relevant scientists

Managerial, Supervisory, Advisory Responsibilities

Structure the DDU-IIT team with appropriate workforce planning and securing appropriate funding.

Supervise all project management, monitoring, pharmacovigilance and data management activities undertaken within the DDU-IIT team.

Oversee staff recruitment and development including objective setting, performance appraisal and training. Remain directly responsible for all such activities for the direct reports