Apheresis & Infusion Principal - Commercial

Job Description

The focus of this position is to provide operational support to Authorized Treatment Centres (ATCs) with the apheresis & infusion process required as part of Vertex gene editing therapy.

The Apheresis & Infusion (AIS) Principal may spend up to 80% of time traveling to ATCs to provide support in relation to 1: activation phase and 2: to support the ATC with execution of the apheresis & infusion process required for a Vertex gene editing therapy.

This position reports to the Director, Apheresis & Infusion.

Note: The AIS will not be providing patient care; the role is to provide technical support to the ATCs for activities that are directly related to the apheresis and infusion process required for Vertex gene editing therapy. To achieve this task, AIS may need to be in the same room as the patient but will have no interaction with the patient.

All the Commercial AIS roles will only be involved in educating the HCPs on the apheresis & transfusion processes at the ATCs to ensure they are able to successfully perform the transfusions for patients. The Commercial AIS roles are not allowed to participate in any clinical trial activities as part of the separation between Commercial and Clinical Development activities.

Key Requirements:

• Relevant experience in conducting apheresis is required and combined educational background.
• Strong apheresis, cellular therapeutics operations, and blood and marrow transplant background/knowledge
• Infusion therapy understanding
• Effective training and strong presentation skills
• Working knowledge or exposure to GCP and GMP
• Must be willing to travel up to 80%; may include weekend travel
• Ability to be succeed in a fast-paced environment
• Ability to work independently with limited supervision
• Effective decision making, priority setting and delegation skills
• Effective training, planning and problem-solving ability
• Detail-oriented and able to assess and assimilate data and communicate objectively
• Excellent collaboration skills; establish good relationships with external stakeholders and internal teams
• Competent computer skills (MS office, Cloud-based programs, Quality Management Systems)
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
• Strong command of English.

Key Responsibilities:

• Work with the Director of AIS, to lead/co-lead Authorized Treatment Centre activities linked to Apheresis & Infusion and drug product operations within given territory
• Evaluates treatment centres as part of ATC activation and confirms to Vertex whether the ATC has the capability to: A - adhere to technical requirements for drug product therapy; B- comply with standards established by the ATCs and all applicable regulatory and licensing bodies
• Provides on-site and/or remote training, oversight, and direction to facilitate the ATC in complying with technical requirements for drug product therapy
• During coverage of collection and infusion procedures, serve as liaison between the ATC staff and Vertex commercial manufacturing and supply chain operations
• Provides on-site / remote (off-site) support to ATC staff as needed to optimize collection and infusion activities. Note: this activity could require being in the same room as the patient but there must not and will not be any interactions with the patient. This may require coordinating travel to coincide with the patient visits.
• Adhere with all applicable policies of the ATC (as informed and required by the ATC) as necessary for the AIS to carry out the AIS role
• Assist with response, mitigation, and escalation of identified or potential issues at or related to ATCs, with robust follow-up of issues and support for ATC improvement efforts
• Serves as a key member of the Vertex cross functional team in the country to provide continuous feedback on ATC performance regarding the apheresis and infusion process required for the Vertex gene editing therapy
• Provides feedback and recommendations to the ATC for apheresis & infusion process improvements and documents, manuals, guides, and work instructions to optimize compliance with the Apheresis & Infusion manuals and the drug product handling guidelines
• Fosters positive collaborative relationships with assigned ATCs
• Is responsible for ensuring all AIS on-site visits and communications are conducted and documented in accordance with (i) Vertex policy; (ii) any agreed requirements of the relevant ATC; and (iii) all applicable laws, regulations and industry codes, and requirements of licensing and regulatory bodies (including local regulations and codes of the country within which the ATC is located).
• Support systems and teams at the ATC in the optimization of collection procedures, efficiency, and quality
• Actively engages in the identification, sharing, and adaptation of best practices with ATCs
• Work closely with the Vertex Commercial Manufacturing and Supply Chain function to ensure the traceability of patient cell collection and drug production infusion through the patient treatment pathway
• Note: AIS is not responsible for providing the following: practice of medicine, provision of patient care, patient interactions, making determinations regarding patient’s eligibility for any treatment, discussing patient condition or treatment, independently collecting data, collecting, or retaining patient personal identifiable information (including health information), or interpreting or advising on the marketing authorization / product license of the Vertex gene editing therapy or any other medicinal product or treatment (outside of the requirements of Apheresis & Infusion manuals and drug product handling guidelines).

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