Position Overview:
Beam is seeking a highly talented and motivated Senior Director, Gene Therapy Operations (Apheresis) leader to join our growing Commercial Patient Operations team. The Senior Director, Gene Therapy Operations will be responsible for leading Gene Therapy Operations, Apheresis team - the team responsible for 1) treatment center onboarding, training and qualification. 2) Patient Scheduling and Coordination for Apheresis and Drug Product Delivery. 3) Cell collection optimization support. 4) Drug Product storage, thawing, and administration support. The leader will be responsible for defining the strategy and scope and building their team, leading treatment center activation and patient coordination. This leader and their team must have a patient-centric and customer-focused approach to drive commercial launch readiness and execution for Beam's lead asset, ristocel, an ex vivo autologous hematopoietic stem cell-based gene therapy for the treatment of severe sickle cell disease (SCD). This is a high impact role for Beam's potential first product commercialization. The successful candidate plays a critical role in building and establishing commercial operations readiness for the company.
Responsibilities:
• Develop and mentor a high performing Gene Therapy Operations, Apheresis team that is focused on delivering an excellent patient and stakeholder experience for commercial gene therapy from scheduling through infusion process. • Develop and execute the strategic initiative and process for Treatment Center Qualification, training and ongoing support for patient coordination, scheduling, communication, cell collection support, and drug product infusion support. • Drive Workflow & Training development: Design training to qualify apheresis and treatment centers, leading treatment center activation and certification processes and providing ongoing operational oversight post-activation. • Quality & Compliance oversight: Ensuring compliance with regulatory standards (FACT, AABB), managing quality records (deviations, CAPAs, change controls) and overseeing the end-to-end process for patient apheresis and product delivery. Ensure COC/COI and assist in the implementation of ISBT-128 ST-018, as needed. • Partner with Quality and Patient Operations team to build a robust treatment center network including center selection, qualification, training and ongoing support. Lead field team providing onsite support. • Provide Apheresis expertise to support various internal activities and external facing training development. • Create and conduct Apheresis and Cell therapy lab on-boarding, assessments, training, and collection support and other areas as needed. • Build metrics program that will drive data collection and analysis in support of optimizing collection procedures, efficiency, and quality. • Actively engage in the identification, sharing, and adaptation of best practices cross-functionally and between centers and identify and champion industry working group initiatives that will improve overall cell and gene therapy industry and treatment experience of our patients. • Work closely across functions to ensure Chain of Identify and Chain of Custody are maintained throughout the patient journey.
Qualifications:
• Bachelors degree or the combination of education and business experience required. • Advanced degree preferred (e.g., MBA, RN, MPH, etc.). • Minimum 10+ years (18+ years) of healthcare or related experience, including significant experience within the biotech industry (especially with cell and gene therapy products). • Strong direct apheresis experience within the last 5 years. • Strong preference for experience within Sickle Cell Disease and autologous cell & gene therapy. • Qualification in Apheresis (QIA) certification preferred. • Ability to work independently with very limited supervision. • Ability to navigate and be successful in a fast-paced, highly matrixed work environment. • Detail-oriented, able to assess and assimilate data and communicate objectively. • Experience in commercial gene or cell therapy is greatly preferred. • Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations. • Effective teaching, training, planning, and problem-solving abilities. • Willingness to travel domestically (30-50% of time). • Strong team player that has patient-focused approach and is solution-oriented. • Excellent listening, communication and interpersonal skills foster team spirit. • Excellent people management skills and a strong track record of developing people/talent and organizational capability. • Passion for addressing the critical unmet medical needs of patients.