Sr. Clinical Supply Chain Manager

4D Molecular Therapeutics•Emeryville, CA

2d•$162,000 - $189,000

About The Position

The Sr. Clinical Supply Chain Manager is a senior, hands-on study supply lead responsible for the strategy, start-up, execution, and lifecycle management of global clinical supplies, with primary emphasis on start-up activities for complex programs. Working independently, the role represents sponsor-side clinical supply on cross-functional study teams and translates protocol, enrollment, country, manufacturing, release, and regulatory assumptions into executable supply strategies. The manager is expected to anticipate supply impacts and lead multiple global study start-ups from protocol development through First Patient, First Visit (FPFV) readiness, establishing scalable supply models, anticipating risks, and making recommendations to senior stakeholders. The position partners closely with Clinical Operations, CMC/Manufacturing, Quality, Regulatory Affairs, Clinical Science, Finance, external vendors, and service providers. The role combines strategic planning with hands-on execution and is responsible for establishing assumptions and critical paths, developing integrated plans, driving cross-functional decisions, and escalating issues with practical options. The role is remote or hybrid, with onsite presence as needed. Periodic domestic or international travel may be required for vendor oversight, study start-up, audits, or critical program activities. The work is sedentary, involving sitting most of the time and only occasional walking or standing; the worker is not substantially exposed to adverse environmental conditions. The base salary range is $162,000–$189,000, with the final offer dependent on factors including location, experience, skills, and years of experience.

Requirements

Bachelor's degree in supply chain, life sciences, pharmacy, or a related discipline.
Minimum 8 years of progressive experience in clinical supply chain, clinical operations supply, or a closely related discipline within biotechnology or pharmaceuticals.
Substantial sponsor-side experience and demonstrated ownership of end-to-end clinical supply activities, rather than experience limited to a single vendor function or execution step.
Proven experience leading at least one complex global Phase 3 study start-up through supply readiness.
Demonstrated expertise in demand forecasting, packaging and labeling, IRT supply design and UAT, global distribution, depot strategy, import/export, inventory and expiry management, accountability, returns, and destruction.
Working knowledge of cGMP, GDP, GCP interfaces, FDA and EMA expectations, and international clinical supply requirements.
Experience selecting and governing external partners, managing budgets and contracts, resolving complex deviations or supply disruptions, and presenting risk-based recommendations to senior stakeholders.
Advanced project leadership, analytical, communication, negotiation, and problem-solving skills, with the judgment to operate independently in a fast-paced, matrixed environment.
Proficiency with IRT, demand-planning and inventory data, Microsoft Excel, and PowerPoint.
Initiative in identifying potential issues and implementing timely corrective actions.

Nice To Haves

Advanced degree or relevant professional certification.
Preferably 4 years of experience working with IRT.
Experience with multi-country, blinded, comparator-controlled, cold-chain, biologic, or advanced-therapy studies.
Experience with GMO requirements and APAC, European, and other global markets.
Experience creating dashboards or portfolio-level supply reporting.

Responsibilities

Own the clinical supply workstream for complex global study start-up from protocol concept and country strategy through site activation and FPFV readiness.
Build and maintain integrated study start-up plans covering demand assumptions, manufacturing and release, packaging and labeling, IRT configuration, depot activation, import/export readiness, site supply, comparator and ancillary sourcing, and contingency stock.
Assess protocol design, treatment arms, randomization, visit schedules, titration or rescue requirements, enrollment assumptions, screen failure, dropout, resupply logic, and geographic expansion for supply impact.
Define supply readiness criteria, identify critical-path dependencies, challenge unrealistic assumptions, and drive decisions and escalations across study teams.
Lead supply scenario planning for accelerated enrollment, manufacturing or release delays, expiry constraints, regulatory delays, country additions, protocol amendments, and other material changes.
Develop and own end-to-end supply strategies for investigational product, comparator, diluent, ancillary materials, and other protocol-required supplies.
Create demand forecasts and supply plans using enrollment, dosing, cohort, country, site, lead-time, expiry, and inventory assumptions; document assumptions and reconcile forecast changes.
Optimize inventory and resupply parameters to protect patient continuity while minimizing waste, overage, expiry exposure, and avoidable manufacturing burden.
Integrate drug product availability, packaging capacity, QA release, shelf life, stability projections, and regulatory constraints into study-level and portfolio plans.
Provide business ownership for clinical supply aspects of IRT design, including supply algorithms, depot and site resupply, inventory status, expiry controls, kit management, UAT, go-live readiness, and ongoing data review.
Establish and oversee global depot and distribution strategies, including lane qualification, cold-chain requirements, import/export documentation, customs readiness, and country-specific requirements.
Monitor inventory health, shipment performance, accountability, returns, reconciliation, destruction, temperature excursions, and other supply exceptions; ensure timely investigation and resolution.
Lead selection, onboarding, governance, and performance management of packaging and labeling vendors, depots, couriers, comparator and ancillary suppliers, IRT providers, and other clinical supply partners.
Develop RFP scope, evaluate proposals, support contract and change-order negotiations, manage budgets and forecasts, and hold vendors accountable for quality, cost, schedule, and issue resolution.
Represent Clinical Supply Chain on study and program teams; communicate status, assumptions, trade-offs, decisions, and risks to operational and senior stakeholders.
Mentor colleagues, provide subject-matter guidance on complex start-up and supply issues, and lead through influence in a matrix environment.
Ensure activities comply with applicable GxP and GDP requirements, company procedures, quality agreements, and global regulatory expectations.
Maintain inspection-ready supply plans, forecasts, decisions, vendor oversight records, inventory documentation, and clinical-material traceability.
Contribute to deviations, investigations, CAPAs, change controls, audits, and inspection support involving clinical supply processes or vendors.
Develop and improve SOPs, templates, governance, metrics, and business processes to enable consistent execution across studies and the portfolio.
Perform other duties as assigned; management may assign or reassign duties and responsibilities at any time.