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Job Summary:

The Director, Clinical Supply Chain Operations & Global Logistics is a senior operational leader responsible for the end-to-end planning, execution, and oversight of clinical supply chain activities supporting the company's global clinical development programs. Reporting directly to the Chief Technical Operations Officer, this individual ensures that investigational medicinal products (IMPs) - spanning small molecules and biologics - are packaged, labeled, distributed, and tracked in compliance with global GMP, GDP, and regulatory requirements, and that clinical sites around the world receive the right product, in the right condition, at the right time. This role is the primary interface between CMC manufacturing, Clinical Operations,, Quality, and external and logistics partners, serving as the operational architect of a global clinical supply network that is reliable, scalable, and inspection ready. In a pre-commercial biotech environment, this leader must balance strategic supply chain design with hands-on execution, building infrastructure and processes that will scale from early-phase trials through global registrational studies.  In addition to clinical supply management, this role is also responsible for shipping, logistics and trade compliance for all material shipments (intermediates, drug substance, drug product and analytical materials) to support the global manufacturing supply chain.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Design and lead the end-to-end clinical supply chain strategy for all active and planned clinical programs, encompassing demand forecasting, inventory planning, clinical packaging and labeling, IRT/IVRS configuration, distribution, and returns/destruction.
• Own the global IMP distribution network, including selection and governance of third-party logistics (3PL) providers, cold chain carriers, and depot partners across North America, Europe, and global regions; ensure temperature-controlled supply chain integrity from CDMO release through site delivery.
• Serve as the primary supply chain interface to Clinical Operations, ensuring clinical supply timelines are fully integrated into study startup plans, protocol amendments, site activation milestones, and enrollment projections.
• Lead clinical supply planning and demand forecasting across multiple concurrent trials, using IRT/IVRS data and enrollment modeling to optimize inventory levels, minimize waste, and prevent supply disruptions to clinical sites.
• Oversee clinical packaging, labeling, and secondary manufacturing activities at CDMO/CMO sites, ensuring compliance with country-specific labeling requirements, GMP expectations, and blinding requirements for randomized controlled trials.
• Manage import/export logistics and global trade compliance for IMP shipments across all active clinical geographies, including coordination of regulatory import permits, customs documentation, and country-specific distribution authorizations.
• Establish and govern relationships with CDMOs, 3PLs, comparator drug suppliers, and specialty logistics vendors; define performance expectations, conduct business reviews, and manage escalations to ensure supply reliability.
• Partner with Quality Assurance to ensure clinical supply chain operations meet GDP/GMP requirements; lead or support regulatory agency inspections, internal audits, and CDMO quality reviews as they relate to clinical supply.
• Build and maintain clinical supply chain SOPs, batch disposition records, chain-of-custody documentation, and reconciliation processes in alignment with ICH E6 (GCP), GMP, and GDP expectations; author and update pharmacy manuals, Investigator Brochure supply sections, and site handling guidance to ensure clinical site readiness across all active studies.
• Lead investigation of supply chain exceptions and deviations, including root cause analysis, CAPA development, implementation, and closure; ensure all supply-related non-conformances are resolved in a timely, GMP-compliant manner and escalated appropriately.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Bachelor's degree required in Supply Chain Management, Life Sciences, Engineering, Pharmacy, or a related discipline; advanced degree (M.S., MBA, or equivalent) strongly preferred.
• 10+ years of clinical supply chain experience in the pharmaceutical or biopharmaceutical industry, with at least 3 years in a leadership role with direct accountability for global clinical supply operations.
• Demonstrated expertise in end-to-end clinical supply chain management, including demand planning, IMP packaging and labeling, IRT/IVRS systems, global distribution, cold chain logistics, and depot management.
• Deep knowledge of global GMP, GDP, and GCP regulations as they apply to clinical supply chain operations, including FDA 21 CFR Parts 211/312, EU GMP Annex 13, and ICH E6(R2); familiarity with country-specific import/export requirements across clinical geographies.
• Familiarity with clinical supply chain management for both small molecules and biologics/large molecules, including specific cold chain and stability considerations for protein-based therapeutics.
• Proficiency with supply chain management tools, ERP/CTMS systems, and clinical supply planning platforms;
• Track record of building clinical supply chain infrastructure, SOPs, and operational processes in a pre-commercial or rapidly scaling biotech organization.
• Demonstrated ability to lead through influence in a matrixed organization, aligning Clinical Operations, CMC, Quality, Regulatory, and Finance stakeholders around supply chain priorities without direct authority over all constituents.
• Proven track record of operating effectively in pre-commercial, resource-constrained environments - building clinical supply infrastructure from the ground up while simultaneously executing against active trial timelines.
• Experience as a trusted operational and strategic partner to senior leaders, with the credibility and judgment to escalate supply risks, recommend course corrections, and drive rapid resolution.
• Strong written communication skills, with experience producing high-quality supply chain status reports, risk registers, executive summaries, and regulatory-facing supply documentation.
• Skilled facilitator with experience leading cross-functional supply chain review meetings, risk escalation discussions, and vendor business reviews with clarity, structure, and decisive follow-through.
• Collaborative communication style with the ability to build credibility and trust quickly across scientific, clinical, operational, financial, and external partner stakeholders in a fast-moving, global biotech environment