Drive commercial supply chain readiness for the company’s first US product launch, including launch planning, launch cutover, operational readiness, and post-launch stabilization.
Develop and maintain an integrated commercial supply chain launch plan aligned with regulatory approval timelines, manufacturing release, quality disposition, channel readiness, and customer availability requirements.
Translate board
approved commercial plans into executable launch demand scenarios, supply volume assumptions, inventory strategies, and operational readiness actions.
Identify launch-critical risks, dependencies, decision points, and mitigation plans across supply planning, distribution, trade, quality, finance, legal, compliance, regulatory, and commercial operations.
Lead development of commercial supply planning processes for demand translation, supply allocation, inventory targets, safety stock, replenishment, expiry management, and launch demand scenarios.
Translate commercial demand plans into supply requirements, forecasts, purchase orders and inventory plans in accordance with applicable supply agreements and contractual obligations.
Develop inventory strategies that balance patient access, launch uncertainty, working capital, shelf life, and supply continuity.
Monitor performance against supply plans and implement corrective actions to address forecast changes, production constraints, distribution disruptions, or demand variability.
Partner with Market Access, Trade, Finance, Legal, Compliance, and Commercial Operations to support channel strategy, distribution model designs, order-to-cash readiness, and customer experience requirements.
Lead operational readiness and ongoing coordination for key commercial distribution processes, including order management, warehousing, returns, recalls support, temperature control, product allocation, and customer service interfaces.
Ensure distribution and logistics capabilities are scalable, compliant, and aligned with launch requirements and future portfolio needs.
Partner with Quality, Regulatory, Legal, and Compliance to ensure commercial supply chain processes comply with applicable regulations, internal policies, and product quality requirements.
Support serialization, track-and-trace, lot traceability, product security, returns verification, and applicable DSCSA-related readiness activities for US commercialization.
Define business requirements for commercial supply chain systems, master data, reporting, partner integrations.
Support creation, review, and implementation of standard operating procedures, work instructions, training materials, and controlled processes required for commercial operations.
Own day-to-day operational management and governance of key external supply chain partners, including 3PL, logistics providers, packaging or labeling partners, and other commercial operations vendors as applicable.
In consultation with the Sr. Director, develop vendor governance routines, performance metrics, business reviews, escalation pathways, and service-level expectations.
Lead issue resolution across external partners and internal stakeholders to protect patient access, supply continuity, and launch timelines.
Support contract input, budget planning, purchase order oversight, invoice review, and operational forecasting for commercial supply chain vendors.
Monitor partner performance against contractual obligations, supply agreements, service levels, forecasts, and launch readiness expectations.
Requirements
Bachelor’s degree in supply chain, operations, life sciences, engineering, business, or a related field required; advanced degree preferred
10+ years of experience in pharmaceutical, biotechnology, or life sciences supply chain, operations, logistics, manufacturing, or commercial operations
Direct experience supporting at least one pharmaceutical or biotech product launch in the United States strongly preferred
Experience managing 3PL, distribution, logistics, specialty pharmacy, specialty distribution, or other commercial supply chain partners
Strong understanding of GMP/GDP expectations, pharmaceutical distribution requirements, serialization, lot traceability, temperature-controlled logistics, and controlled commercial processes
Experience building supply chain processes, operating models, vendor governance, launch readiness plans, and cross-functional ways of working in a growing organization
Demonstrated ability to lead launch-critical workstreams with a high degree of ownership while partnering closely with senior functional leadership
Strong analytical, project management, communication, and executive-ready presentation skills
Comfort operating in an entrepreneurial, pre-commercial environment where processes, systems, and teams are still being built
Experience anticipating launch risks proactively and driving clear ownership of mitigation actions
Experience with ERP, planning tools, order management, serialization systems, partner integrations, and/or launch readiness dashboards
Experience developing S&OP or integrated business planning processes in a pre-commercial or early commercial biotech setting preferred
Balances strategic design with hands-on execution, is well-organized, proactive and detail oriented