Apheresis & Infusion Specialist (AIS), Assoc. Director

Role Summary

The Apheresis & Infusion Specialist (AIS), Associate Director will be a customer-centric member of the team that is able to self-lead in an ever-evolving environment, embody mental resilience, maintain a strategic problem-solving mindset, and effectively collaborate with internal and external stakeholders. The successful candidate will bring a strong clinical understanding of cell and gene therapy with the ability to manage complex treatment logistics with regulatory and compliance requirements. They can think broadly, strategically, and thrive in a fast-changing environment and possess exceptional organizational and time management skills. The focus of this position is to provide education, training and support to Authorized Treatment Centers (ATCs) regarding key points in the cellular therapy process relating to the Vertex gene editing therapy, including apheresis, packaging and shipping, final product receipt and storage, as well as infusion. This is a field-based position based in the south-central US.

Responsibilities

• Deliver excellent stakeholder experience for commercial operations of Vertex gene therapy.
• Strong customer focus, intent on building relationships with the key ATC stakeholders to help ATCs optimize patient outcomes related to the product.
• Engage in site qualification, partnering with cross-functional Vertex team members to evaluate treatment centers, ensuring their ability to conduct activities associated with assigned commercial requirements including compliance with standards established by the applicable regulatory and licensing bodies including FACT, FDA, AABB, etc.
• Participate in cross-functional onboarding meetings with ATC team members to provide cell therapy expertise to help support the patient journey.
• Provides on-site and/or remote education, training, and support, to facilitate applicable product handling and labeling requirements. May involve some work outside of normal business hours as dictated by treatment center needs.
• Participate as key member of the Apheresis & Infusion Specialist team as well as the Commercial field team.
• Partner with the ATC quality team to identify and resolve quality events
• Collaborate with internal cross functional partners to identify areas of responsibility that contribute to process improvement and the launch of cell and gene therapy.
• Work closely with the manufacturing and supply chain functions to ensure the traceability of patient cells throughout the patient treatment journey.

Qualifications

• Preferred: Minimum of 7 years of experience, with 3-5 years of recent (within 2 years) blood and marrow transplant experience
• Preferred: Strong apheresis and/or cellular therapeutics knowledge and experience
• Preferred: Experience with clinical trials, research activities, or commercial cell & gene therapies
• Preferred: Effective decision making, priority setting and time management skills.
• Preferred: Demonstrated confidence with presenting, teaching and training in a group setting.
• Preferred: Proficient computer skills (MS office, Cloud-based programs, Quality Management Systems)
• Preferred: Must be willing to travel up to 70%; may include weekend travel
• Preferred: Ability to be flexible in a fast-paced environment working with urgency to meet stakeholder needs.
• Preferred: Ability to work efficiently and independently in a field ‚Äìbased role with limited supervision.
• Preferred: A solid compliance mindset and demonstrated integrity on the job.
• Preferred: Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.

Education

• Bachelor's degree required