Senior Clinical Supply Manager/Associate Director

Role Overview

• Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs
• Support IWRS User specifications and UATs
• Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs
• Manage supplier relationships with vendors including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements
• Evaluate vendor selection to support clinical study supply chain according to capability and fit
• Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support
• Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts
• Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy. Oversee international depots and distribution as appropriate
• Support governance committees for global clinical operations and global clinical supply chain
• Ensure consistency across processes and develop tools to implement sustainable improvements
• Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness
• Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables
• Support regulatory filings including IND and BLA submission information as it relates to a global supply chain
• Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements
• Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development)
• Additional responsibilities as needed

Requirements

• Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s degree in Supply Chain Management preferred
• Minimum 5 years of experience handling/leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level
• Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred
• Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design
• Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
• Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels
• Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP
• Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
• Extensive experience in planning and execution of investigational materials supply strategies
• General knowledge of GxP principles is required

Tech Stack

• Google Cloud Platform