Director/Senior Director, Clinical Supply Chain

About the role

The position is highly cross-functional and will work with Quality Control, Quality Assurance, CMC, development team, regulatory, and external vendors. The Director or Senior Director of Supply Chain will represent Supply Chain function for Viking to define and operationalize Supply Chain system, to support clinical material manufacturing globally, and to determine distribution strategy for the lifecycle of products from pre-IND through post launch.

Responsibilities

• Lead end-to-end clinical supply chain strategy from early development through late-stage trials, ensuring uninterrupted supply across global studies.
• Develop study-level and program-level demand forecasts, supply strategies, and risk mitigation plans (expiry, overage, country-specific requirements, comparator sourcing, and protocol amendments).
• Serve as the primary supply chain representative in cross-functional teams including Clinical Operations, CMC, Regulatory, QA, and external partners.
• Select, qualify, and manage all clinical supply vendors, including CMOs, packaging/labeling partners, depots, couriers, and IRT/RTSM providers.
• Oversee vendor performance, KPIs, quality expectations, supply continuity, and issue resolution.
• Ensure service providers operate under robust quality agreements and comply with GMP, GDP, and regional regulatory requirements.
• Maintain complete traceability for all investigational and auxiliary materials using lot, batch, or kit-level identification as required.
• Ensure timely reconciliation of GMP inventory and accurate visibility across CMOs and clinical depots.
• Direct global distribution strategy, including temperature-controlled logistics, import/export management, and customs/permit requirements.
• Ensure shipments are executed in compliance with IATA, GDP, and applicable country regulations.
• Lead investigation and resolution of temperature excursions, deviations, and product handling issues.
• Own clinical supply chain SOPs, work instructions, and process improvements to support inspection readiness.
• Partner with QA to ensure compliant execution of GMP/GDP activities and maintain audit-ready documentation.
• Support regulatory submissions with supply-related content (IND, CTA, NDA/MAA modules as applicable).
• Build and manage clinical supply budgets, forecasts, and cost-saving strategies.
• Drive continuous improvement initiatives to streamline supply operations and enhance scalability as programs progress.

Requirements

• Bachelor’s, or equivalent in Biology, Chemistry, Pharmacy or relevant discipline.
• 10+ years of industry experience in Supply Chain and/or Operations and/or Product and/or CMC experience.
• NDA, BLA, IND, or MAA submission experience is a plus.
• Familiarity with inventory management systems preferred.
• Knowledge of global shipping and logistics requirements for pharmaceutical materials.
• Working knowledge of FDA-regulated environments and applicable compliance expectations.
• Knowledge of GMP quality-controlled storage and shipping processes, including cold chain logistics.
• Knowledge of import/export documentation requirements, including permits, licenses, and declaration letters for global distribution of live virus banks, cell banks, and raw materials.
• Ability to work effectively with third-party vendors supporting shipping and logistics services.
• Ability to review and author SOPs related to clinical supply chain operations.
• Knowledge of GMP warehouse inventory organization and management within biotech, pharmaceutical, or consumer goods environments.
• Technical working knowledge of product packaging or design preferred.
• Ability to thrive in a fast-paced, dynamic, and fluid company environment with minimal direction and shifting priorities.
• Strong critical thinking and troubleshooting skills.
• Able to contribute to the development of new concepts, techniques, and standards and recommend modifications to operating policies.
• Strong communication and interpersonal skills, with the ability to build effective working relationships across all levels of the organization.
• Strong computer skills, including proficiency with Microsoft Office and the ability to quickly learn new applications.

Pay

$200,000.00 - $220,000.00 annual salary