Job Description

The Director, Apheresis & Infusion (AI) Operations, will oversee the team responsible for ensuring A uthorized T reatment C enters (ATCs) are following product label requirements during apheresis and infusion activities. This role will be based in the IHQ office at Paddington and will lead a team of AIS principals who are field based and operating in different countries .

Key Duties & Responsibilities

The Director will be responsible for leading a team of AIS Principals across International at Vertex as we work closely with the ATCs in multiple countries and HCPs to treat patients living with Sickle Cell Disease (SCD) and Transfusion-dependent ?-thalassemia (TDT). This individual will require an innovative professional with the breadth of experience and drive to implement the vision for this function and work collaboratively with external and cross-functional partners. The Director may be required to spend up to 3 0% of time traveling to cell & gene therapy authorised treatment centers to ensure the team of AIS Principals are providing the required technical support on the apheresis and infusion-related execution of the cell & gene therapies, including cell collection, handling of drug product, and infusion. They will be a key member of the operations team working on cell and gene therapies. Provides clear direction around Apheresis & Infusion and drug product handling activities to the country AIS teams. Lead, manage, coach and provide direction and guidance to the country AIS teams who are the direct reports . Ensures alignment and collaboration with the broader global apheresis teams in Boston to ensure best practice sharing Evaluates treatment centers as part of ATC activation and confirms to Vertex whether the ATC has the capability to: Conduct activities associated with the requirements of the Apheresis & Infusion manuals and the drug product handling guidelines C omply with standards established by the ATCs and all applicable regulatory and licensing bodies (including, JACIE, EMA, MHRA and local country regulations etc). Ensure AIS team p rovides on-site and/or remote training, oversight, and direction to facilitate the ATC in complying with the requirements of the Apheresis & Infusion manuals and the drug product handling guidelines Ensure that d uring coverage of collection and infusion procedures, AIS team serve s as liaison between the ATC staff (Apheresis, Cellular Therapy Laboratory, and Transplant Unit) and the Vertex commercial manufacturing and supply chain operations Ensures AIS team p rovides 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 role will not be providing patient care but rather observing the activities at the hospital that are directly related to label requirements. A customer support-oriented mindset is essential for this role. Support in establishing an Apheresis and Infusion Operations function that is focused on delivering an excellent patient and stakeholder experience as it relates to the collection of patient cells and infusion of Drug Products consistent with the product's label and in compliance with local laws and regulations. Evaluates treatment centers to ensure ability to conduct activities associated with product handling and manufacturing label requirements and comply with standards established by the hospital and all applicable regulatory and licensing bodies including FACT, FDA, AABB, etc. Develop a metrics program for the team to assess appropriate key performance indicators as it relates to evaluating and training a network of cell collection treatment centers . Ensure enhancement and implementation of an industry leading training program for the education of internal and external stakeholders in cell collection and infusion processes Responsible for ensuring all on-site visits and communications By A IS team are conducted and documented according to GCP and all applicable licensing and regulatory bodies Serves as a key member of operations and other cross functional teams as needed Enhance systems and teams to collect insights to support optimization efforts related to collection procedures, efficiency, and quality Work closely with the Supply Chain & Quality teams to ensure the traceability of patient cell collection and drug production infusion through the patient treatment pathway D evelop a highly motivated team effecting the best customer interactions possible AIS is not responsible for the following: practice of medicine, patient care, decisions regarding patient's eligibility, discussing patient condition or treatment, independently collect data, retain patient health information (PHI), or interpret or advise on the product label

Required Education Level

Bachelor's degree (BSC/BA)

Required Experience

Typically requires significant r elevant work experience Significant experience in healthcare and related experience or the equivalent combination of education and experience Apheresis, transplant nursing, or cell therapy lab experience

Required Knowledge/Skills

Strong clinical experience in a hospital setting Recent (within 2 years) blood and marrow transplant experience Infusion therapy, involving complex therapies Strong apheresis and/or cellular therapeutics operations background/knowledge Experience conducting clinical trials and/or supporting commercialized cell & gene therapy products Ability to work independently with very limited supervision Outstanding interpersonal skills with the ability to motivate others, influence, and negotiate conflicting situations Effective decision making, priority setting and delegation skills Effective teaching, training, planning and problem-solving abilities Strong understanding and leadership in pharmaceutical and healthcare compliance Detail-oriented, able to assess and assimilate data and communicate objectively Experience analysing and interpreting economics/financial performance as well as developing scalable processes for an expanding business. Excellent Leadership, mentoring/coaching, communication, collaboration, and presentation skills Competent computer skills (MS office, Cloud-based programs, Quality Management Systems) BMT clinical nursing or coordinator experience Qualification in Apheresis (QIA) certification preferred Good knowledge of GCPs, GMPs, AABB, FACT, FDA, regulations Must be willing to travel up to 3 0% of the time.
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 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 exa-cel patients. The AIS roles are not allowed to participate in any clinical trial activities.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.


Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.