Senior Clinical Supply Chain Manager
1 week ago
Senior Clinical Supply Chain Manager
Location:
Phoenix, AZ (Arizona time zone preferred;)
Department:
Clinical Operations / Supply Chain
Type:
Full-time, Direct Hire
Position Overview
We are seeking a
Senior Clinical Supply Chain Manager
to lead end-to-end clinical supply activities across global clinical programs. This is a hands-on, high-impact role ideal for a dynamic professional with experience in life sciences, early-stage biotech, or startup environments.
You will manage clinical material planning, procurement, packaging, labeling, logistics, and distribution while collaborating with internal teams and external partners including CMOs, distributors, central labs, and CROs. Success in this role requires strong project management skills, adaptability, and comfort working within small, fast-growing teams.
Key Responsibilities
Clinical Supply Planning & Forecasting
- Lead forecasting of investigational and ancillary supplies based on enrollment projections, dosing schedules, and study timelines.
- Develop supply plans to ensure continuous product availability while minimizing waste.
- Maintain scenario models and risk mitigation plans for enrollment variability and study changes.
Procurement & Vendor Management
- Source and procure investigational products, comparators, reference standards, and ancillary materials.
- Manage relationships with CMOs, packaging vendors, logistics partners, and central/distribution labs.
- Negotiate contracts, oversee supplier performance, and ensure vendor deliverables.
Packaging, Labeling & Distribution Oversight
- Coordinate packaging, labeling, and kitting activities with external partners, ensuring global regulatory compliance.
- Oversee cold-chain and specialized logistics from manufacturing sites to depots and trial sites worldwide.
- Manage import/export documentation and country activation readiness.
Inventory & Supply Operations
- Monitor depot and site inventories, including temperature excursions, returns, and reconciliation.
- Use digital tools to ensure real-time supply visibility and prevent shortages or overstocking.
- Lead IRT set-up and supply strategies.
Regulatory, Quality & Compliance
- Ensure all supply chain activities comply with GMP, GDP, GLP, and regulatory requirements.
- Support audits and inspections with robust documentation and oversight.
- Collaborate with Quality to maintain documentation integrity, change controls, and deviation management.
Cross-Functional & Project Leadership
- Serve as the primary supply chain liaison to Clinical Operations, Quality, CMC, and Regulatory.
- Lead supply-related workstreams, deliver project updates, and maintain master project plans.
- Provide input into protocol design to ensure supply feasibility and optimized patient experience.
Risk & Technology Management
- Use dashboards and project management systems to maintain real-time supply visibility.
- Identify operational risks and implement strategies for continuity, scalability, and cost efficiency.
- Establish processes appropriate for a fast-growing small company while ensuring compliance.
Qualifications
Required
- Bachelor's degree in Life Sciences, Supply Chain, Engineering, or related field.
- 7+ years of clinical supply chain experience in biotech, pharmaceuticals, or life sciences.
- Strong project management skills with cross-functional leadership experience.
- Hands-on experience with CMOs, distributors, labs, depots, and logistics partners.
- Proficiency with GMP, GLP, GDP, international labeling requirements, and regulatory expectations.
- Experience in small or early-stage companies with willingness to roll up sleeves and execute.
- Excellent organizational, analytical, and time-management skills.
- Proficiency with inventory/order management software (Cin7 or similar).
Preferred
- Experience supporting Phase I–III global clinical trials.
- Knowledge of IRT systems and clinical supply software.
- Prior involvement in startup or rapid-growth environments.
- Familiarity with lab operations, central lab workflows, and sample logistics.
Soft Skills
- Exceptional communication skills, able to translate complex information to diverse audiences.
- Collaborative team player who builds trust across internal and external stakeholders.
- Flexible and adaptable, comfortable with shifting priorities in a growing company.
- Proactive problem-solver who thrives in dynamic, hands-on environments.
- Detail-oriented and highly organized, maintaining accuracy under tight timelines.
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