p>KNOWLEDGE/SKILLS/ABILITIES REQUIRED: Complete and advanced understanding cGMP and cGCP requirements for clinical and commercial supply chains Strong leadership skills; demonstrated ability to build/lead a team and influence at all levels of the organization Ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion Strong analytical, problem solving and critical thinking skills Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners Experience in managing third-party clinical supply operations Experience in building and managing inventory management systems Experience in building and managing strong teams Comprehensive knowledge of IRT design for control of drug distribution and inventory management Knowledge of import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance Strong understanding of IMP, QP, cGMP and cGCP practices and requirements Bachelor's degree in scientific/pharmacy field A minimum 15+ years of leadership experience in Clinical Supply and Supply Chain operations required Available to travel if/when needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead the overall Supply Chain Team, with a focus on optimization, flexibility, risk analysis and planning Serve as a mentor and coach for career development of the supply chain team Acts as the main liaison within Clinical Operations, Manufacturing, Quality, and external partners to support key tasks related to forecasting, planning, shipping, logistics, labeling, packaging and distribution of clinical materials and future commercial distribution Manage country logistics for shipping and importation and monitoring of enrolment, drop-out rates and actual supply needs.