Key Accountabilities

• Set the strategic vision and operating model for the end-to-end clinical supply chain across allogeneic and in vivo programs, including supply architecture, inventory positioning, clinical packaging and labeling, depot strategy, cold chain requirements, lane design, and site delivery models fit for each modality.

• Own and evolve the clinical supply strategy at the portfolio level, translating study designs, enrollment forecasts, pipeline progression, and manufacturing constraints into integrated supply plans with clear assumptions, scenario planning, and risk mitigations.

• Build and develop a high-performing team responsible for clinical supply execution from startup through study completion, ensuring uninterrupted IMP delivery to patients across all active sites and geographies.

• Architect the order management and fulfillment model, including demand signal through delivery confirmation, allocation logic, release-to-ship workflows, inventory replenishment, and site coordination — establishing governance and escalation frameworks to sustain operational excellence.

• Define and oversee distribution network operations, including selection and governance of logistics providers, packaging and shipping configuration, regional depot partners, temperature monitoring, transit validation, and country-specific import/export requirements for biological materials.

• Serve as the primary interface to Clinical Operations to provide recommendations to Global Study Teams and Leadership, including risks and mitigations, required decisions, and ensure clinical supply timelines are fully integrated into study startup plans, site activation milestones, and enrollment projections. 

• Provide oversight of clinical packaging and labeling operations at third parties, including country-specific requirements to ensure timely clinical regulatory submissions and clinical study milestones.

• Drive clinical site enablement strategy from a supply chain perspective, including site feasibility, import pathway confirmation, lane qualification, site-level delivery requirements, and training material development.

• Establish exception management and escalation frameworks, ensuring rapid triage of supply disruptions, cross-functional mobilization, and decisive action to protect patient dosing.

• Define the technology and systems roadmap for off-the-shelf modality clinical supply operations, including inventory visibility, shipment and order execution, order tracking, milestone reporting, and exception alerting — partnering with IT and digital teams to drive implementation through enterprise systems (SAP) and alignment with future order-to-cash requirements.

• Champion continuous improvement and organizational learning, capturing lessons learned, building scalable practices, and shaping the transition strategy as programs advance toward registration and potential commercialization.

• Influence cross-functional and enterprise-level decisions by representing clinical supply operations in governance forums, contributing to portfolio planning, and ensuring supply chain readiness is embedded in program milestones.

• Partner with Commercial Operations to design the future clinical-to-commercial supply chain transition, including distributor engagement models, channel strategy, and site-of-care delivery frameworks that support future commercial readiness.

Essential Qualifications

• Bachelor's degree in Supply Chain, Life Sciences, Engineering, Business Administration, or related field.

• 12+ years in clinical supply chain management, with progressive leadership responsibility for global clinical trial supply strategy, design, startup, and execution in complex, regulated environments.

• Demonstrated people leadership experience, including building, mentoring, and developing teams in matrixed, global organizations.

• Proven track record with inventory-based, temperature controlled clinical supply models, including demand planning, depot distribution, lane qualification, carrier oversight, import/export readiness, inventory visibility, cold chain logistics, and multi-country IMP delivery at scale.

• Deep expertise in clinical distribution networks in cell and gene therapy or specialty biologics space— depot strategy, distributor and 3PL operating models, lane qualification, carrier management, packaging/shipping configuration, and temperature-controlled logistics for biological products.

• Strong working knowledge of ICH-GCP, FDA, EMA, GDP, GMP, and applicable regulations for clinical supply and IMP distribution.

• Demonstrated ability to build capabilities and organizations from the ground up — operating models, process design, systems requirements, governance structures, and documentation where established playbooks don't exist.

• Executive-level cross-functional collaboration and influence across Clinical Operations, CMC, Manufacturing, Quality, Regulatory, and external partners — with the ability to shape decisions at the program and portfolio level.

• Strategic mindset paired with operational rigor — comfortable operating at both the enterprise strategy level and stepping into tactical detail when needed to protect patient dosing.

• Flexibility for global time zones as needed.

• Experience designing or implementing order-to-cash/ order fulfillment processes for biologics, vaccines, or other inventory-based clinical/commercial supply models.

Desirable Skills/Experience

• Advanced degree (MS or MBA)

• Experience in cell therapy, gene therapy, ATMP, or advanced biologics clinical supply

• Experience with cryogenic or ultra-cold chain logistics for biological products

• Experience with trade compliance or import/export of biological materials in clinical supply

• Supply chain certification (CSCP, CPIM)

• Experience leading supply chain functions through late-phase clinical programs and commercial transition planning.

• Track record of presenting to and influencing senior leadership or governance bodies on supply chain strategy and investment decisions.

#CellTherapy

The annual base pay for this position ranges from $144K to $212K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.