Senior Director, Commercial Product and Vein-to-Vein Systems Operations

Position Overview:

Beam is seeking a highly talented and motivated Senior Directory, Commercial Product and Vein-to-Vein Systems Operations leader to join our growing Commercial Patient Operations team.  The Senior Directory, Commercial Product and Vein-to-Vein Systems Operations will be responsible for 1) Driving the end-to-end chain-of-identity and chain-of-custody (COI/COC)  traceability process; including electronic portal system build in partnership with VP, Patient Operations and IT. 2) Defining and Owning a commercial exceptions management framework, including investigation, escalation, root-cause analysis, and preventive action for patient-specific product events. 3) Treatment center qualification oversight and maintenance, in partnership with Quality and Gene Therapy Operations Teams. This role will be responsible for designing and executing end-to-end validation and writing to support FDA submission. In partnership with Quality and Gene Therapy Operations, this role will define the process, SOPs and training needed to onboard, activate and maintain treatment center qualification to bring a transformative and differentiated therapy to Patients. This role is focused on ristoglogene autogetemcel (risto-cel), formerly known as BEAM-101, an investigational genetically modified ex vivo base editing cell therapy, in patients with sickle cell disease (SCD) with severe vaso-occlusive crises (VOCs).

Responsibilities:

Vein‑to‑Vein Governance & Commercial Readiness

• Establish and lead cross‑functional governance for commercial product execution, including clear ownership, escalation pathways, and decision rights.
• Drive readiness for regulatory inspections and audits related to commercial product operations and patient‑specific execution.
• Partner with Commercial, Patient Operations, Gene Therapy Operations, Quality, Supply Chain, and IT to ensure aligned and disciplined execution from order to infusion.

Chain of Identity / Chain of Custody (COI/COC) Ownership

• Define and execute the COI/COC validation strategy, including SOPs, workflows, risk assessments, and control points across the full patient journey.
• Translate FDA, FACT, AABB, and other regulatory requirements into practical, auditable, end‑to‑end workflows.
• Own COI‑related deviation investigations with commercial impact, partnering with Quality and Operations to resolve issues and prevent recurrence.

Exception Management & Escalation

• Design and lead a commercial exceptions management framework covering incoming apheresis material, manufactured drug product, logistics, scheduling, and site readiness issues.
• Lead investigations, root‑cause analyses, escalation management, and CAPA development across Commercial Product Operations in partnership with Manufacturing, Supply Chain, Quality, and Patient Operations.
• Provide clear, timely communication of execution risks, trends, and mitigation plans to senior leadership.

Digital Workflow & Traceability Portal Ownership

• Serve as the business and product owner for Beam’s workflow and traceability portal, partnering with IT on design, build, validation, and ongoing enhancements.
• Define system requirements, user roles, data standards, reporting needs, and compliance controls.
• Drive disciplined adoption of portal workflows across internal teams, treatment centers, and external partners.

Treatment Center Qualification & Enablement

• Partner with Quality to lead Treatment Center Qualification and maintenance, including contracting, evaluation, gap analysis, and compliance with FACT, AABB, and FDA standards.
• Define and execute end‑to‑end processes, SOPs, and training for treatment center onboarding, activation, and ongoing qualification.
• Ensure centers are operationally ready to execute COI‑compliant apheresis, product receipt, and infusion in a patient‑specific commercial environment.

Metrics, Insights & Continuous Improvement

• Collaborate with Patient Operations and cross‑functional partners to define and track metrics for COI/COC performance, exception trends, and portal compliance.
• Build a metrics program to support data‑driven optimization of commercial product and system operations for risto‑cel.
• Use insights to drive continuous improvement ahead of and through commercial launch.

Qualifications:

• Bachelor's degree or the combination of education and business experience required.
• Minimum 10+ years of Quality Management, System Management or Commercial Product Operations in Cell and Gene Therapy.
• Experience supporting FDA BLA submission, inspection and commercial launch required.
• Experience building or maintaining traceability portal for cell or gene therapy required.
• Experience with Treatment Center Qualification and Activation for cell and gene therapy required.
• Strong direct cell or gene therapy commercial experience within the last 5 years.
• 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.
• Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations.
• Effective teaching, training, planning, and problem-solving abilities.
• Willingness to travel domestically (20% of time).
• Strong team player that has patient focused approach and is solution oriented.
• Excellent listening, communication, and interpersonal skills foster team spirit.
• A passion for addressing the critical unmet medical needs of patients.

Key Competencies

• Strong cross‑functional vein‑to‑vein execution leadership.
• Calm, accountable decision‑making in patient‑specific, high‑stakes environments.
• Excellence in escalation management and risk communication.
• Collaborative, solutions‑oriented, and patient‑focused mindset.
• Outstanding listening, communication, and interpersonal skills.