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GENERAL SUMMARYThe 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 study start-up activities for complex programs. Working with a high degree of independence, this role serves as the sponsor-side clinical supply representative on cross-functional study teams and translates protocol, enrollment, country, manufacturing, release, and regulatory assumptions into an executable supply strategy. This role will also need to have an in-depth understanding of the required study start-up activities and can anticipate potential supply impacts.
The role is expected to lead multiple global study start-ups from protocol development through First Patient, First Visit (FPFV) readiness, establish scalable supply models, anticipate risks before they affect study milestones, and provide clear recommendations to senior stakeholders. The position partners closely with Clinical Operations, CMC/Manufacturing, Quality, Regulatory Affairs, Clinical Science, Finance, and external vendors and service providers.
The successful candidate operates as a study supply lead, not solely as a logistics coordinator. They can enter a complex Phase 3 start-up, quickly establish the assumptions and critical path, create an integrated plan, drive cross-functional decisions, and escalate early with practical options. They combine strategic planning with hands-on execution and can stabilize a study before transitioning routine operational management as appropriate.
MAJOR DUTIES & RESPONSIBILITIES:Study Start-Up Leadership
- Own the clinical supply workstream for complex global study start-up, from protocol concept and country strategy through site activation and First Patient, First Visit (FPFV) readiness.
- Build and maintain integrated start-up plans with the team covering demand assumptions, manufacturing and release, packaging and labeling, IRT cross-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 ramps, 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 delay, expiry constraints, regulatory delay, country additions, protocol amendments, and other material changes.
Clinical Supply Strategy and Forecasting
- 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.
IRT, Distribution, and Inventory Oversight
- 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.
Vendor and Cross-Functional Leadership
- 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 and provide subject-matter guidance on complex start-up and supply issues; lead work through influence in a matrix environment.
Quality, Compliance, and Operational Excellence
- Ensure activities are performed in accordance with applicable GxP and GDP requirements, company procedures, quality agreements, and relevant global regulatory expectations.
- Maintain inspection-ready supply plans, forecasts, decisions, vendor oversight records, inventory documentation, and traceability of clinical materials.
- 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 that enable consistent execution across studies and the portfolio.
- Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS: Education:
- Bachelor's degree in supply chain, life sciences, pharmacy, or a related discipline; advanced degree or relevant professional certification is preferred.
Experience:
- Minimum 8 years of progressive experience in clinical supply chain, clinical operations supply, or a closely related discipline within biotechnology or pharmaceuticals with preferably 4 years of experience working with IRT.
Other Qualifications/Skills:
- 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; experience with multi-country, blinded, comparator-controlled, cold-chain, biologic, or advanced-therapy studies is strongly preferred.
- 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 with GMO requirements and APAC, European, and other global markets is preferred.
- 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, and Microsoft Excel and PowerPoint. Experience creating dashboards or portfolio-level supply reporting is preferred. Takes initiative in identifying potential issues and implementing timely corrective actions.
Travel:
- Remote or Hybrid role with onsite presence as needed.
- Periodic domestic or international travel may be required to support vendor oversight, study start-up, audits, or critical program activities.
Physical Requirements and Working Conditions:
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $162,000 - $189,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
