Director, Commercial Supply Chain

ITF Therapeutics•Concord, MA

2d•Hybrid

About The Position

The Director of Commercial Supply Chain is a critical leadership role responsible for the compliant, reliable, and high-quality execution of U.S. Commercial Supply for a rare disease pharmaceutical product. Operating with substantial independence in a lean organization, this role owns end-to-end Commercial Supply Chain Operations and serves as the primary interface to external manufacturing, packaging, and logistics partners. This position ensures uninterrupted Commercial Supply through strong contract manufacturer relationship management, disciplined supply planning and S&OP governance, robust 3PL and cold-chain oversight, and close partnership with CMC, Quality, Regulatory, Finance, and Commercial teams. The role carries direct accountability for supply chain compliance, risk management, and operational resilience across manufacturing, distribution, serialization and import/export activities.

Requirements

Bachelor’s degree required
7–10+ years of progressive experience in commercial supply chain and/or technical operations within pharma, biotech, rare disease, or other highly regulated environments.
Strong track record managing external manufacturers, packagers, and 3PL partners supporting commercial supply.
Deep knowledge of GDP, 21 CFR, 19 CFR, USP standards, DSCSA, cold-chain distribution, and import/export compliance.
Demonstrated experience with S&OP, supply planning, inventory lifecycle management, investigations, CAPAs, and change control governance.
High degree of independence, sound judgment, and leadership effectiveness in lean organizations.

Nice To Haves

Advanced degree (MBA/MS) preferred.
Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach.
Experience with rare and ultra-rare disease therapeutics at development and commercial stages is highly desirable.

Responsibilities

Serve as the primary Supply Chain / Tech Ops interface to Contract Manufacturing Organizations (CMOs), packagers, and other Contract Service Providers (CSPs) as appropriate.
Lead relationship management with external partners, ensuring alignment on production schedules, capacity commitments, lead times, materials readiness, and issue resolution.
Partner with CMC and Quality to support commercial manufacturing readiness, ongoing supply execution, investigations, CAPAs, and post-approval change management impacting U.S. supply.
Participate in manufacturing and supply governance forums; assess and mitigate risks related to capacity, materials, yield variability, and performance.
Lead day-to-day U.S. commercial supply chain operations, including 3PL oversight, warehousing, order fulfillment, GDP-compliant temperature-controlled distribution, and last-mile delivery.
Ensure flawless execution of customer shipments, including order release, temperature-controlled performance, deviation management, and root cause resolution.
Oversee inbound shipments from external manufacturers, including carrier and broker management, import documentation, and compliance with U.S. Customs (19 CFR).
Maintain audit-ready documentation and resolve operational exceptions through disciplined corrective and preventive actions.
Own creation and maintenance of the U.S. supply plan within the planning platform, ensuring alignment with demand forecasts and visibility to risks and constraints.
Lead Supply Review activities as part of the monthly S&OP process; prepare plan-to-actuals, risk assessments, and scenarios for executive decision-making.
Develop annual and rolling long-range supply plans; assess and endorse mid-cycle changes as business needs evolve.
Develop scenarios and prepare recommendations for U.S. inventory strategy, including safety stock, inventory health, expiry exposure, lifecycle management, and write-off risk mitigation.
Lead and/or support supply-chain-related quality events, including deviations, nonconformances, complaints, and temperature excursions.
Initiate and manage change controls impacting manufacturing, packaging, labeling, distribution, and handling; conduct global change control impact assessments.
Ensure distribution and supply practices comply with GDP, 21 CFR, 19 CFR, USP, DSCSA, and applicable federal and state regulations.
Support ERP implementation and optimization; govern master data accuracy and transactional discipline across ERP, planning tools, and 3PL systems.
Serve as supply chain SME for serialization, partnering with 3PLs and channel partners to ensure DSCSA compliance and exception resolution.
Develop and maintain KPI dashboards across supply reliability, inventory performance, service levels, forecast accuracy, compliance, and cost.
Support supply chain budget development, contract execution, PO governance, and financial variance analysis.
Strengthen operational resiliency, compliance maturity, and scalability of commercial supply chain and tech ops processes.
Act as primary deputy to the Head of Supply Chain, providing functional leadership, cross-functional representation, and decision-making authority as required.