Director, Supply Chain

This position can be either office (Plano, TX) or remote-based and manages supply chain activities for global clinical and US commercial activities.

RESPONSIBILITIES:

• Plans, establishes, manages, and monitors forecast activities related to drug substance, drug product, and clinical supplies for Reata's clinical programs
• Operational planning to support the commercial supply of finished goods to US 3PLs
• Ensures uninterrupted clinical supplies, maintains/tracks inventory of available clinical supplies, and tracks expiration dates
• Coordinates with QA partners to manage technical and quality issues to facilitate uninterrupted supplies
• Serves as the primary point of contact with packaging, labeling, and distribution vendors for assigned clinical development stage programs
• In collaboration with the Commercial team, serves as the primary Supply Chain point of contact with third-party logistics providers for commercial supply
• Responsible for scheduling and delivery of CTM including strategies for creating label and packaging design, randomization, packaging, labeling, and distribution of clinical supplies
• Manages external consultants and third-party vendors, including vendor selection and agreement development for clinical packaging and distribution, to ensure timely and quality delivery of investigational products that meet study protocol, regulatory, and budgetary requirements
• Develops and manages the forecasting of investigational product, commercial, and comparator material in global trials and market areas and shares best practices with global/local sourcing teams as appropriate
• Manages and monitors spending and tracks budgets, purchase orders, and invoice approval for clinical packaging and distribution
• Provides guidance, mentoring, and development of a clinical supply team and ensures the team has appropriate skills, capabilities, systems, and resources to meet current and future business needs

• Demonstrate commitment and support for company goals, objectives, and procedures
• Demonstrate good fiscal management
• Represent Reata by developing collaborative relationships with site personnel, colleagues, and vendors
• Demonstrate professionalism and adherence to moral, ethical, and quality principles
• Participate in corporate and departmental meetings

• Bachelor's degree in Supply Chain or related discipline or equivalent qualifications in Business Administration, Logistics, or Materials Management
• At least 10 years of relevant clinical development stage and/or commercial supply chain, warehouse/distribution operations in the pharmaceutical or related industry
• Working knowledge of cGMP, GCP, and relevant ICH and FDA guidelines
• Leadership experience with supply chain development and oversight, establishing improvement objectives, and delivering results within tight project deadlines
• Experience managing within a virtual manufacturing environment or a smaller biotech organization is preferred
• Demonstrated skills in Materials Management
• Knowledge and understanding of supply chain timelines in the pharmaceutical industry
• Knowledge and understanding of global distribution practices, including importation and exportation of pharmaceutical materials
• Previous experience in materials management, logistics, distribution, and supply chain is preferred
• Demonstrated ability to organize information, with translations into planning and monitoring inventory and budgetary items associated with Materials Management
• Strong analytical skills and ability to manage risks
• Comfortable working in a small company virtual environment (all activities outsourced)