Clinical Supply (Senior) Manager/Associate Director

Primary Responsibilities

• 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 

Required Skills and Qualifications

• 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