Director, Clinical Supplies & Logistics

About the role

The Director, Clinical Supplies & 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.

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.

Requirements

• 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.
• Experience: 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.
• Expertise: 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.
• Regulations: 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.
• Tools: Proficiency with supply chain management tools, ERP/CTMS systems, and clinical supply planning platforms;
• Infrastructure: Track record of building clinical supply chain infrastructure, SOPs, and operational processes in a pre-commercial or rapidly scaling biotech organization.
• Leadership: 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.
• Communication: Strong written communication skills, with experience producing high-quality supply chain status reports, risk registers, executive summaries, and regulatory-facing supply documentation.
• Collaboration: 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.

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.
• Experience: 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.
• Expertise: 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.
• Regulations: 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.
• Tools: Proficiency with supply chain management tools, ERP/CTMS systems, and clinical supply planning platforms;
• Infrastructure: Track record of building clinical supply chain infrastructure, SOPs, and operational processes in a pre-commercial or rapidly scaling biotech organization.
• Leadership: 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.
• Communication: Strong written communication skills, with experience producing high-quality supply chain status reports, risk registers, executive summaries, and regulatory-facing supply documentation.
• Collaboration: 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.

Skills

• Supply Chain Management
• Global GMP, GDP, and GCP Regulations
• ERP/CTMS Systems
• Supply Chain Planning Platforms
• Relationship Building
• Stakeholder Alignment
• Regulatory Compliance
• Supply Chain Exception Handling

Benefits

• Competitive health and wellness coverage
• Paid time off, public holidays, and additional leave entitlements
• Flexible work arrangements / hybrid schedule

Pay

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Schedule

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.