Director, Global Clinical Supply Continuous Improvement (Onsite)

Position Overview

The Global Clinical Supply (GCS) organization is within our Research & Development Division and is accountable for managing the end-to-end integrated clinical supply chain across the portfolio to enable the execution of any clinical trial. GCS supports more than 300 Phase I-IV clinical trials run in-house, 400+ outsourced or run by partners, and 300+ ISS clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, in accordance with US and WW regulations, company policies and Standard Operating Procedures.

The Director, Continuous Improvement, will lead Continuous Improvement activities across the organization supporting a CI culture. The role will oversee both strategic and tactical improvement initiatives, kaizen workshops, and cultural activities and will support the roll out of significant metrics as key performance indicators (KPIs), contributing to the overall governance of the performance oversight in GCS. The role will ensure the education of the organization in continuous improvement and lean methodology, project management, change management, knowledge management, quality by design, and appropriate risk management through coaching and mentoring belt candidates and trainees for the community of practice. The leader will play a key role in talent development within his/her team and the overall GCS organization.

Primary Activities

The Director, GCS Continuous Improvement, will be accountable for identification, prioritization, and execution of continuous improvement activities in GCS and across partner organizations, including process improvement, change management efforts, and After-Action Reviews (AARs). The incumbent will engage a client group within GCS and be responsible for the implementation of continuous improvement culture, tools, and education across the organization. The Head, CI will closely collaborate across GCS, Global Clinical Trial Operations (GCTO), Global Development Quality (GDQ), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Data Management, Translational Medicine, and the Research & Development Division (including Quality Assurance/QA and IT).

• Actively create a culture in which Continuous Improvement becomes the organizational norm.
• Process design/improvement projects/strategic initiatives across the organization.
• Continuously identify opportunities to improve, simplify, standardize, and optimize processes in collaboration with functional areas.
• Analytics & Metrics - Develop and maintain performance, quality, and compliance related analytics and metrics (reports, dashboards, Key Performance Indicators/KPIs).
• Seek ways to innovate and/or further automate the use of data and new capabilities.
• Identify, train and coach in lean concepts.
• Continuously evaluate opportunities for creating additional connectivity, and share learnings, between partner organizations.

Education & Experience

• Bachelor's degree or equivalent experience required.
• A graduate degree in scientific discipline would be beneficial.
• A LSS black belt certification or equivalent experience is required.
• Extensive experience in facilitating kaizen workshops and leading complex projects.
• Understanding of Clinical supply chain and clinical trials including GCP & GMP.

Skills

• A dedication to solving complex and challenging problems with a creative mind and imaginative strategies.
• Strong influencing and negotiation skills.
• Ability to lead, create future state, and deliver results.
• Over five years in the implementation of a variety of lean six sigma tools to evaluate and improve business processes with at least five years coaching and leading process improvement teams.
• Demonstrated ability to develop strong, trust based, collaborative relationships to drive change and execute on priorities with a diverse group of stakeholders.
• Strategic thinking and independent decision-making abilities.
• Demonstrated ability to communicate clearly, effectively and tactfully to interact with different global professional levels and external stakeholders.
• Proven track record of successful deployment of continuous improvement projects, across different modalities and business units.
• Must have strong understanding of GMP, GCP, and data integrity expectations from regulatory agencies.
• Excellent written and verbal communication.