Beeline Medicines - Director, Clinical Supply Chain Operations & Global Logistics
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. • 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
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
Benefits
• 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. • $214,849 - $227,040 USD • We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to: • Competitive health and wellness coverage (structure and premiums vary by country) • Paid time off, public holidays, and additional leave entitlements in accordance with local requirements • Flexible work arrangements / hybrid schedule • Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process. • Equal Employment Opportunity:
Apply in one click
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT