Director Cell Therapy Operations

Proclinical is seeking a Director of Cell Therapy Operations (NHS Cell Therapy/Car-T Nurses transitioning to industry) to oversee and build the Cell Therapy Operations team. This role focuses on launching an autologous T-Cell immunotherapy, providing operational and quality expertise to healthcare professionals. The successful candidate will oversee the authorization activities of commercial centres and manage the team post-launch.

Responsibilities:

• Collaborate with the EX-US team for operational and quality expertise.
• Serve as a subject matter expert on JACIE, tissue, and cellular therapy regulations in Europe.
• Conduct operational meetings with healthcare professionals to establish a standard of care pathway.
• Develop key performance indicators and meet timelines for treatment centre authorization.
• Build and maintain relationships with key stakeholders at treatment centres.
• Lead cross-functional meetings to develop product and patient workflows.
• Develop or review Standard Operating Procedures (SOPs) for Treatment Centres.
• Address and prioritize post-launch issues and needs of treatment centres.
• Oversee tumour collection, product receipt, storage, distribution, and TIL infusion.
• Approve changes to collection, courier tracking, order intake, and processing systems.
• Lead the centre qualification process using risk-based tools.
• Develop and execute training for authorized users.
• Oversee Chain of Identity and Chain of Custody at Treatment Centres.
• Support quality records and participate in advisory board meetings.
• Develop and execute training plans and materials for the Operations Team and healthcare providers.
• Create and enhance training modules using virtual adult learning principles.
• Streamline workstreams and SOPs related to treatment centre qualification and monitoring.
• Partner with Quality, Legal, and HR to manage training records.
• Ensure compliance with corporate policies and healthcare regulations.

Key Skills and Requirements:

• BA or BS degree required; advanced degrees and certifications preferred.
• Fluency in English; French and German preferred.
• Experience in a medical or pharmaceutical environment, including nursing, surgical oncology, and cellular therapy.
• Leadership and team management experience.
• Competence in needs assessment, facilitation, prioritization, decision making, collaboration, planning, organizing, implementation, and follow-up.
• Strong written and verbal communication skills.
• Ability to present compelling and influential oral presentations.
• Management skills and operational capabilities.
• Ability to perform under pressure and meet deadlines.
• Strong organizational and prioritization skills.
• Excellent customer service skills and ability to troubleshoot and resolve issues.
• Proficiency with Microsoft Office Suite.
• Ability to travel up to 50% of the time.

If you are having difficulty in applying or if you have any questions, please contact Vishal Desor at v.desor@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.