Senior Manager, Clinical Supply Chain

Senior Manager Clinical Supply Chain needs 5-7 years in life sciences industry related experience including Project Management Pharmaceutical Development Clinical Supply Management and/or Clinical Trials Coordination.

Senior Manager Clinical Supply Chain requires:

• BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
• Minimum 5-7 years in life sciences industry related experience including Project Management Pharmaceutical Development Clinical Supply Management and/or Clinical Trials Coordination
• 3 years in Clinical Supplies Management. Proficient knowledge of Microsoft Excel PowerPoint and Project software required. APICS certification (CPIM CLTD CSCP) preferred.

Senior Manager Clinical Supply Chain duties:

• Lead and manage end-to-end Clinical Supply Chain activities (planning packaging and labeling distribution returns and destruction) for assigned clinical programs in early and late phases. Develop and manage supply forecasts supply plans and timelines in collaboration with Clinical and CMC.
• Manage IP inventory levels at the depots and clinical sites; coordinate the inventory from manufacturer to depot or clinical sites. Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
• Ensures effective management of IP based on study timing and in accordance with clinical protocols cGMP GCP ICH FDA and other applicable international federal and/or local regulations.
• Collaborate closely with Clinical Operations CMC Regulatory Affairs QA and PDM to ensure advancement of clinical programs; ensure supplies readiness.
• Manage clinical supply and logistics and resolve issues such as shipment delays temperature excursions import/export; work closely internal Trade Compliance & Logistics team. Demonstrates a solid understanding of clinical study design (randomized blinded open label etc.) and execution.
• Manage assign clinical trial contracts purchase orders including invoices and budget for clinical supply vendor; participate in CSC budget and forecast planning. Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
• Responsible for managing drug supply planning inventory control and distribution activities including label/pack scheduling issue resolution change implementation vendor oversight and scope review related to clinical supplies on multiple clinical programs.
• Work closely with CMC Regulatory Affairs Quality Assurance Clinical Operations and /or SMPA external partners and CMOs as needed building strong working relationships support study project teams and ensure timely Investigational Product (IP) for clinical trials.