Senior Manager, Clinical Supply Chain

In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or CLIENT external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials. Duties: 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.

Duties:

• 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.
• In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or CLIENT external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials.

Skills:

• 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. 

Education:

• 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. · At least 3+ years in Clinical Supplies Management.
• Proficient knowledge of Microsoft Excel, PowerPoint, and Project software required.
• APICS certification (CPIM, CLTD, CSCP) preferred.