Director, Apheresis Operations

Position Description:

The Director, Apheresis Operations, is a leadership role within Patient Operations and is responsible for providing strategic and operational oversight of the apheresis operations team that supports Genetix’s three commercially approved therapies. This role is field based and requires frequent travel to Qualified Treatment Centers (QTC) to engage with our customers and care teams in-person. This role will develop and expand the strategic partnerships and relationships with external partners and evolve the internal team to meet the demands of our growing commercial business. The ideal candidate will enhance and expand on the existing technical and medical knowledge of the organization. The apheresis operations team is a highly skilled and technically knowledgeable group of individuals responsible for: 1) QTC onboarding, training, qualification, 2) data analytics and metric tracking on collections, 3) onsite/remote cell collection support and optimization, and 4) final Drug Product infusion support.

This role partners closely with Manufacturing, Quality, Commercial, Patient Management & Logistics, Medical, and Systems Teams to ensure uninterrupted, world class patient and customer support.

This position is a hybrid position based out of our Somerville, MA location. Domestic travel 50% or more of the time is required for this role.

Job Duties and Responsibilities:

Core Responsibilities:

• Lead, engage, evolve, and elevate the Apheresis Operations team to match evolution of our commercial business
• Extensive technical expertise, with strong focus on medical and apheresis operations experience
• Gather and analyze key data metrics, perform KPI tracking to inform continued improvements to our process and patient journey experience

Field Responsibilities:

• Travel domestically, 50% or more of the time across our national QTC network for engaging internal and external collection teams, cell therapy labs, treating physicians and teams, and patients as required to provide individualized, white glove customer service and establish partnership with teams involved
• Set the standard of relationship management and communications for the apheresis operations team, provide internal team coaching and field training

Other Responsibilities:

• Serve as subject matter expert for internal and external apheresis education
• Partner with Quality, Technical Development & Operations, and Commercial teams to build a robust treatment center network including center selection, qualification, training and ongoing support
• Oversee and drive the strategy and process improvements for QTC qualification, training, ongoing support
• Ensure compliance with regulatory standards and requirements, oversee management of team owned quality system records, (deviations, CAPAs, change controls, proactive initiatives)
• Drive the identification, sharing, and adaptation of best practices cross-functionally and between centers that will improve overall treatment experience of our patients

Essential/Required Qualifications:

Required:

• Bachelor of Science in Nursing (BSN), Registered Nurse (RN), Qualification in Apheresis (QIA) preferred, or minimally, Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 10+ years of progressive experience in Apheresis Operations, Cell and Gene Therapy, Commercial Operations, Treatment Centers
• Prior people leadership experience at the Associate Director or Director level within the industry
• Demonstrated experience leading a field-based team, and working in the field
• Knowledge of GMP regulations (FDA, EMA, ICH)
• Direct apheresis experience within the last 5 years
• Domestic travel, 50% or more of the time
• Passion for bringing curative therapies to patients

Preferred Qualifications:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy
• Experience working in BioPharma

Key Competencies:

• Primary focus on driving process improvements which have a demonstrable impact on the business
• Enhance apheresis technical knowledge, utilizing this expertise to educate internal and external groups. Key focus on how to improve collections, show up with executive presence at conferences, drive and oversee apheresis summits to be a leader in the industry
• Excellent communication and partnership with internal and external groups and individuals
• Detail oriented, anchor to and utilize data to drive sound business decisions
• Strategic thinking, with an ability to translate into operational plans
• Ability to adapt to fluctuating relationship dynamics with internal and external partners
• Excellent listening and conflict management skills. Team player, flexible to the needs of a wide range of personalities