Director, Cell Therapy Vein-to-Vein Operations

Accountabilities

• Lead the Vein-to-Vein Operations function, with accountability for organizational design, role clarity, decision rights, governance, ways of working, and execution performance across the end-to-end patient and product journey.
• Own the Vein-to-Vein Operations operating model centered on patient and order orchestration, proactive patient journey management, customer experience, and digitally enabled control tower visibility.
• Establish and lead the V2V orchestration model, including the 24/7 global control tower mindset and the operating rhythms required to monitor product and patient journeys in real time and intervene proactively.
• Lead product journey monitoring capability, ensuring all critical milestones across collection, manufacturing, transit, release, and return delivery are visible, monitored, and linked to timely operational response.
• Own slot execution and coordination capability, ensuring the organization can effectively manage the forecast-to-booked slot pipeline and operate within defined planning rules and capacity parameters.
• Ensure robust V2V and COI/COC traceability, including appropriate business process ownership, standard templates, process controls, and operational discipline required to maintain traceability and GMP/GDP compliance.
• Own exception management and escalation capability, ensuring clear playbooks, decision pathways, and cross-functional escalation processes are in place when patient or product journeys move off the expected path.
• Lead courier and logistics provider engagement for active Vein-to-Vein journeys, ensuring real-time milestone visibility, escalation of off-path events, and coordinated recovery actions for shipment delays, temperature excursions, missed milestones, and other transport-related disruptions impacting patient timelines.
• Lead customer experience delivery for treatment centers and internal stakeholders by establishing service expectations, communication standards, escalation pathways, and a coordinated end-to-end experience in collaboration with Patient Operations.
• Own operational performance management across Vein-to-Vein Operations, including service reliability, milestone adherence, exception trends, customer experience, and execution quality.
• Build and Lead cross-functional governance and decision-making for operational, compliance, capacity, and service issues impacting V2V execution.
• Ensure operational readiness and scale-up for new studies, countries, sites, third parties, products, lanes, digital capabilities, and Commercial readiness impacting Vein-to-Vein Operations.
• Partner with Digital and business stakeholders to ensure systems, workflow design, reporting, and data structures support the intended V2V operating model and real-time visibility requirements that will scale for the future.
• Drive continuous improvement across the function by identifying structural issues, prioritizing enhancements, and strengthening the operating model for reliability, scalability, and customer experience.
• Provide strong people leadership, building and leading a high-performing team through clear direction, coaching, development, performance management, and a culture of accountability, collaboration, and continuous improvement.

  Essential Skills/Experience

  • 10+ years (or MS/MA/MBA with 8+ years) in logistics operations at pharma/biotech or leading clinical supply or logistics providers; cell therapy experience preferred.
  • Minimum education: a Bachelor’s degree in Supply Chain, Engineering, Life Sciences, Operations, or a related field.
  • Extensive experience in biopharma supply chain, cell therapy operations, clinical logistics, or related operational leadership roles, typically including 12+ years of relevant experience, with substantial experience in autologous Vein-to-Vein operations and complex regulated environments.
  • Demonstrated success leading complex operational organizations with accountability for people leadership, operating model design, execution, governance, performance, and continuous improvement.
  • Deep understanding of patient and order orchestration, COI/COC traceability, slot execution, product journey monitoring, exception management, and specialized cold chain or time-sensitive logistics.
  • Strong experience building or leading scalable operating models, control tower or real-time monitoring capabilities, business process ownership frameworks, and cross-functional ways of working in regulated environments.
  • Experience supporting clinical-to-commercial transition, commercial readiness, global expansion, or operational scale-up in cell therapy or similarly complex supply environments.
  • Demonstrated ability to lead through complexity, influence senior stakeholders, and align teams across Clinical Operations, Manufacturing, Quality, Supply Chain, Digital, Trade Compliance, and external logistics partners.
  • Strong understanding of GDP, GMP, GxP, deviation management, CAPA, and inspection-readiness expectations.
  • Excellent communication, leadership, and stakeholder management skills, with the ability to translate strategic direction into scalable operational capability and a high-performing team culture.

    Desirable Skills/Experience

    • Advanced degree such as MS, MBA, or equivalent.
    • Experience building or leading a control tower, centralized operations, or real-time operational monitoring capability.
    • Experience supporting clinical-to-commercial transition, launch readiness, global expansion, or operational scale-up in cell therapy or advanced therapies.
    • Experience with Power BI, Tableau, Excel, Smartsheet, or similar tools for performance visibility and operational analytics.