Director/Senior Director, Clinical Supply Chain
$200k - $220kScorpion Therapeutics
Responsibilities Lead end-to-end clinical supply chain strategy (early development to late-stage trials) ensuring uninterrupted global supply. Develop demand forecasts, supply strategies, and risk mitigation plans (expiry/overage, country requirements, comparator sourcing, protocol amendments). Serve as primary supply chain representative across Clinical Ops, CMC, Regulatory, QA, and external partners. Select, qualify, and manage clinical supply vendors (CMOs, packaging/labeling partners, depots, couriers, IRT/RTSM providers) and oversee KPIs, quality expectations, continuity, and issue resolution. Ensure providers meet GMP/GDP and regional regulatory requirements under robust quality agreements. Oversee clinical labels/packaging configurations, master batch records, distribution documentation, and lot/batch/kit traceability. Reconcile GMP inventory and maintain visibility across CMOs/depots. Own global distribution strategy (temperature‑controlled logistics, import/export, customs/permits) and ensure compliance with IATA/GDP/country rules. Investigate temperature excursions/deviations; manage IRT/RTSM configuration and change control; map kit numbers/expirations/resupply logic/depot allocation. Own clinical supply SOPs/work instructions/process improvements; partner with QA; support IND/CTA/NDA/MAA supply content; manage budgets/forecasts. Requirements Bachelor’s degree in Biology, Chemistry, Pharmacy, or related field. 10+ years in supply chain, operations, product, or CMC roles. Submission experience (IND/BLA/NDA/MAA) preferred. Familiarity with inventory management systems. Skills/Knowledge Pharmaceutical global logistics; FDA‑regulated environments; GMP cold chain storage/shipping. Import/export documentation knowledge (permits, licenses, declaration letters for biologics/raw materials). Vendor management; ability to author/review SOPs; GMP warehouse inventory management. Strong troubleshooting, communication, and Microsoft Office proficiency. Salary Salary: $200,000–$220,000 annual salary. #J-18808-Ljbffr Scorpion Therapeutics
$217k - $275k
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