Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery

Role Summary

Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery. This role is based remotely, reporting to the Head, Clinical Site Startup and Engagement Process Excellence and Delivery.

Responsibilities

• Works directly with the Head of Process Excellence & Delivery to develop and execute CSSE strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE, Global Development Office (GDO) and Research & Development (R&D).
• Assist with building new capabilities for the CSSE organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working.
• Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates.
• Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans.
• Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process.
• Ensure implementation of new/updated processes and technologies are in compliance with quality standards (including ICH, GCP, local regulations and Takeda SOPs).
• Ensure that crucial strategic and operational cross-organizational issues/projects/initiatives are addressed efficiently and track progress of initiatives, working with teams and leaders across R&D functions.

Education and Experience

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable.
• 7 or more years’ experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical trial development and delivery process.
• 7 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
• Experience in people leadership, managing global teams, change management and coordinating collaboration with cross-functional teams.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
• Strong strategic thinking, planning, execution, and communication skills.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.