[Remote] Senior Manager, Clinical Supply Chain

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing company focused on fighting cancer. The Senior Manager of Clinical Supply Chain will manage drug supply activities for clinical studies, ensuring accurate supply while minimizing waste and risk, and will represent the Clinical Supply Chain to reputed company stakeholders.

Responsibilities

• Represent the Clinical Supply Chain on Clinical Study Teams (CST) and reputed company a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC)
• Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines
• Create supply and inventory plans and reputed company production schedules for clinical trial materials
• Monitor schedule adherence of production schedules and reputed company course corrections if needed
• Manage GMP inventory throughout the supply chain, reputed company inventory reports, manage upcoming expiry, and ensure drug accountability
• Manage the relationship and reputed company daily activities for FG label & pack CMOs and distribution vendors
• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
• Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
• May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs
• Support IRT user acceptance testing, reputed company IRT supply strategy (DNX parameters), and reputed company ongoing supply activities in system
• Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses
• reputed company supply strategies to maximize supply efficiency, minimize waste while identifying risk and reputed company risk mitigation plans
• reputed company cross functional projects and process improvements reputed company to drug supply
• Creates and/or revise process documents such as Standard Operating Procedures
• Additional responsibilities as required
• Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management

Skills

• Bachelor's or Master's degree in Business Administration, Operations Management, or a reputed company field required
• Minimum of 7 years of reputed company experience in supply chain, preferably reputed company the biotech, pharmaceutical, or CRO industry
• Has working knowledge of clinical supply best practices, IRT systems, as well as experience working reputed company a cGMP environment

Benefits

• Non-reputed company roles are eligible to participate in the annual bonus plan
• reputed company roles are eligible to participate in an incentive compensation plan
• reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
• reputed company are eligible to voluntarily participate in the Employee Stock Purchase Plan
• The Company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Overview

Company H1B Sponsorship