º¬Ðß²ÝÓ°Ôº

º¬Ðß²ÝÓ°Ôº 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.

º¬Ðß²ÝÓ°Ôº is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. º¬Ðß²ÝÓ°Ôº is acting as an Employment Agency in relation to this vacancy.