Associate Director, Strategic Vendor Oversight

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 120 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.   

Job Summary:

The Associate Director, Strategic Vendor Oversight is a subject matter expert accountable for the development, implementation, training, maintenance, and management of Global Clinical Operations (GCO) vendor oversight activities, in alignment and compliance with GCP, GCLP, and ICH E6(R2) guidance, as well as other scientific, operational, and regulatory requirements. This individual will guide GCO in scaling for the future portfolio and vendor partnership needs to achieve its goals. The scope of the role includes study concept through end-to-end operationalization to maximize the value and efficiency of best in practice vendor oversight, continuous improvements, and a proactive inspection readiness approach to support Daiichi Sankyo's (DSI's) global strategy. Vendor oversight includes various sourcing models including full-service outsourcing, tactical agreements, and FSP. This individual oversees adherence to regulatory requirements and GCP guidelines through the reporting of KPI/KQI, and by agile process improvements. •This individual will be accountable for implementing and maintaining metrics that support efficient and effective vendor oversight for our clinical trials (establishes criteria to measure the overall health of the process and execution on the oversight plan).

Responsibilities:

• Responsible for building capabilities and technical skills within GCO to ensure effective delivery of vendor/CRO oversight.

• Create and implement vendor oversight training programs and guidance documents by role/function within GCO.

• 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.

• Responsible for the guidance, training, and support of GCO staff on the how to’s of CRO/Vendor oversight.

• Provides guidance to GCO team members to improve operational efficiency, effective at prioritization, and problem identification and solving.

• Reviews business and operational processes and procedures to make recommendations to support operational enhancements; identifies opportunities for continuous improvement and adoption of emergent relevant methodologies, tools, templates, and applications to ensure fit-for-purpose and simplified and effective processes that support efficient and beneficial vendor oversight activities.

• Identify process improvement initiatives related to vendor/CRO oversight in Clinical Operations; partner with functional excellence to establish plans and execute key initiatives and assesses their impact.

• Analyzes data/metrics/key performance indicators to support vendor/CRO oversight of clinical trials.

• Partners with RD Excellence and Clinical Trials Business Operations (CTBO) to develop or select optimal reports for review at performance and delivery.

• Contributes to aggregate depictions of quality performance by asset or vendor for enterprise thinking. Collaborate with CQA and GCO quality to ensure inspection readiness based on this output.

• Support qualification/requalification of vendors, as appropriate.

• Maintain awareness of vendor oversight guidance and trends in the external landscape and evolve DS GCO with these trends.

• Works with Global Clinical Operations, as needed, to understand business priorities.

• Participates in key cross functional teams, as needed.

• Understand and monitor internal and external requirements and standards and ensure appropriate implementation and usage of templates and processes.

• Develop and establish more streamlined ongoing vendor management with the Procurement team, helping to shape future ways of working at DSI.

• Role does not currently have direct reports but there is a possibility of line management.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's degree in chemistry, biology, pharmacy, or other scientific discipline (7 years relevant experience is required with a bachelor's degree) required.

• Master's Degree 5 years relevant experience is required with a master's degree.

Experience:

• 2 years relevant experience is required with a PhD Experience Qualifications.

• 7 or More Years leading or managing clinical trial management or quality assurance activities in the pharmaceutical or biotech industry preferred.

• 4 or More Years in roles related to risk management / RBQM activities preferred.

• Familiarity with global regulations and common practices related to Risk Based Quality Management preferred.

Travel:

• Ability to travel up to 10% In-house office position that may require travel (domestic).

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.