Director, Clinical Trial Operational Risk

4 weeks ago

Trenton, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), will collaborate with the Head, Alliance & Vendor Oversight, CQM, and Process to build a GCO CTOR&O structure, ways of working, tools, and meaningful communication pathways with functional partners to support GCO risks. This individual will also lead and manage the GCO CTOR and Strategic Vendor Oversight teams, will partner with GCO leaders, subject matter experts (SMEs), and other functional area partners to ensure GCO risk management activities are executed and continuously monitored for effectiveness, efficiencies, and areas of improvement.

Respo

nsibilities:

Clinical Trial Operational Risk (CTOR) Management: Build and manage GCO CTOR structure and group to support GCO risks. Manage and oversee the CTOR team who support GCO Quality by Design, risk and issue management. This team will also be responsible for creating and managing tools to support GCO operational risks and other day-to-day CTOR activities to support study teams. As needed, involved in due diligence activities during the vendor selection process. Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners. Close partnership with clinical quality management and other compliance functions within and outside of GCO, process owners, and other support functions, to ensure a continued practice centered on Quality by Design, Clinical Trial Risk Management, efficient Issue Management, and Continuous Improvement. Supports SVO in development of vendor management oversight plans.

Strategic Vendor Oversight (SVO):

Oversee and manage the SVO group who are responsible for building capabilities, training and technical skills within GCO to ensure effective delivery of vendor/CRO oversight and creating and managing CRO metrics and dashboards. Drive overall culture of GCP compliance, vendor oversight importance (ICH E6(R2) requirements), and regulatory inspection-readiness. Ensure alignment on CRO/Vendor oversight standard practices across GCO and work with Global Clinical Operations, as needed, to understand business priorities. Develop and establish more streamlined ongoing vendor management with the Procurement team, helping to shape future ways of working at DS. Provides guidance to GCO team members to improve operational efficiency, effective at prioritization, and problem identification and solving. Identify process improvement initiatives related to vendor/CRO oversight in Clinical Operations; As needed, partner with functional excellence to establish plans and execute key initiatives and assesses their impact. Understand data/metrics/key performance and quality indicators to support vendor/CRO oversight of clinical trials. Maintain awareness of vendor oversight guidance and trends in the external landscape and evolve DS GCO with these trends.

Additional Collaboration Opportunities: For internal audits and Health Authority inspections, this organization provides support, as needed, to the central study teams in collaboration with CQM to ensure the timely development of CAPA responses to promote a continuous improvement of identified issues. Provide support to objectives, workstreams, and strategic imperatives, as needed. When needed, collaborate with CTBO, CQM, AM, and SVO to develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and evaluate risks/issues across GCO and effectiveness of initiative and/or process implementation. Monitor key risk metrics and partner with SMEs to identify and address gaps/deficiencies Present metrics and trend analysis to key stakeholders in Global Clinical Operations and GDO Leadership, as needed

People Management: Conduct performance evaluations against goals for direct reports. Coach and guide their functional and/or direct reports in support of their development needs and provide real-time feedback on job performance. Develop plan for resourcing of activities within remit/scope. Ensure appropriate resources (employee and/or contractor-based) are available to support current and future clinical programs and studies. Drive a feedback-oriented culture Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications:

(from an accredited college or university) Bachelor's Degree Bachelor's degree with minimum of 10 years in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement and project management a plus. required Experience Qualifications Strong experience and expertise in end-to-end clinical operations functional understanding and execution, including experience in clinical trial/protocol design and implementation Required required Additional experience and expertise in end-to-end clinical trial execution in one or more key functions (e.g. clinical research & development, clinical science, clinical quality assurance, project management) Preferred required Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management Required required Additional experience in process improvement activities and implementation Required required Understanding of regulatory and industry guidance trends with ability to apply them to risk management improvements Required required Licenses and Certifications Six Sigma certification preferred

Travel: Ability to travel up to 10% In-house office position that may require travel (global).

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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