Director, Clinical Supply Logistics and Distribution — Cell Therapy

• Set the strategic vision and operating modelfor 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 strategyat 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 teamresponsible 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 strategyfrom 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 roadmapfor 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 decisionsby 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.

• Bachelors 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 tobuild capabilities and organizations from the ground up operating models process design systems requirements governance structures and documentation where established playbooks dont 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.

• Advanced degree (MS or MBA)

• Experience incell therapy gene therapy ATMP or advanced biologicsclinical supply

• Experience withcryogenic or ultra-cold chain logisticsfor biological products

• Experience withtrade compliance or import/export of biological materialsin 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 incentivesan 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.