Director, Clinical Supplies & Logistics
New
B
Beeline MedicinesBiotechnology
Location: United StatesFull-TimeDirector
Salary$214,849 — $227,040 USD
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Job Details
- Experience
- 10+ years of clinical supply chain experience in the pharmaceutical or biopharmaceutical industry, with at least 3 years in a leadership role.
- Required Skills
- GCP
Requirements
- Bachelor's degree in Supply Chain, Life Sciences, Engineering, Pharmacy, or related field (advanced degree preferred).
- 10+ years of clinical supply chain experience in the pharmaceutical or biopharmaceutical industry.
- Minimum 3 years in a leadership role with accountability for global clinical supply operations.
- Demonstrated expertise in end-to-end supply chain management (demand planning, IMP packaging, IRT/IVRS, global distribution, cold chain).
- Deep knowledge of global GMP, GDP, and GCP regulations (FDA 21 CFR, EU GMP Annex 13, ICH E6(R2)).
- Experience with clinical supply chain for both small molecules and biologics.
- Proficiency with supply chain management tools, ERP/CTMS systems, and clinical supply platforms.
- Proven track record building infrastructure and SOPs in a pre-commercial or rapidly scaling biotech organization.
- Ability to lead through influence in a matrixed organization across Clinical, CMC, Quality, and Regulatory stakeholders.
- Strong written communication skills for creating risk registers, status reports, and regulatory documentation.
- Skilled in leading cross-functional meetings and vendor business reviews.
Responsibilities
- Design and lead the end-to-end clinical supply chain strategy including demand forecasting, inventory planning, packaging, labeling, and IRT/IVRS configuration.
- Own the global IMP distribution network, managing 3PL providers and ensuring cold chain integrity from CDMO release to site delivery.
- Serve as the primary supply chain interface to Clinical Operations, aligning supply timelines with study startup, protocol amendments, and enrollment.
- Oversee packaging, labeling, and secondary manufacturing at CDMO/CMO sites ensuring compliance with blinding requirements and GMP.
- Manage import/export logistics and trade compliance, coordinating regulatory permits and customs documentation.
- Establish and govern relationships with vendors, CDMOs, and comparator suppliers, leading business reviews and performance monitoring.
- Partner with Quality Assurance to ensure operations meet GCP, GMP, and GDP requirements, leading or supporting regulatory inspections and audits.
- Author and maintain clinical supply chain SOPs, chain-of-custody documentation, and site-handling guidance.
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