Associate Director, R&D CTMS Operations Lead

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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, R&D CTMS Operations Lead will lead the business operations team in one or more systems/capabilities with the R&D functional area, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of, and interactions with, CROs and other external vendors to ensure deliverables are conducted according to the timeline, budget and quality metrics set forth by the study team and according to the internal plan set forth by the relevant business areas. Acting as an escalation point for any sponsor oversight issues and CRO quality issues.

This role will be accountable for the operational strategy, tactics and overall delivery of the Operations services as it pertains to the business area, including but not limited to: Global SOP adherence, operational agreement between DS and CROs/vendors, QA, and IT. This position may require line management responsibility of data maintenance specialists, who are primarily responsibility for the data maintenance and quality checks to ensure that the trial information is up to date from data integrity and accuracy stand point.

• Required experience as the lead for the operational aspects of the Clinical Trials Management System.

• Provides leadership and manages CTMS Operations team and responsible for ensuring high quality and accurate data through standardized CTMS processes and disciplines.

• This role is the single point of accountability for CTMS Study Data quality, compliance, and inspection readiness.

Responsibilities:

Operations leadership, planning, and oversight:

• Leads operations team globally or regionally with a One DS mindset for the relevant systems/capabilities, as applicable.

• Accountable for the operations and data health of the area at all times ensuring standardization and harmonization of processes.

• Develops and maintains KPIs and metrics to check the operational data health; highlights risks and issues; and develops mitigation plans to address gaps.

• Single Point of Contact for liaising with RD functions, non-RD stakeholders, other internal peer operations teams and CROs/vendors that are critical for the systems/areas.

• Communicates and actively collaborates with managers and leaders regarding the operational processes and organizational goals and/or objectives.

• Closely collaborates with the Business Owner (BO) to implement strategic and tactical decisions in the systems area.

• Leads documentation of SOPs (Standard Operating Procedure)/SOIs (Standard Operating Instruction) and WIs (Work Instruction) as applicable and ensures they are kept up to date.

• Assesses operational gaps and leads continuous service improvement initiatives to challenge status quo and enhance operational effectiveness and efficiency.

• Accountable to ensure the operational area is always inspection/audit ready and leads the operations team during inspection/audits.

• Leads and/or supports the implementation of CAPAs in relation to sponsor’s audit or regulatory inspection.

CRO/Vendor Oversight:

• Provides oversight of the CRO/Vendor to ensure compliance with Daiichi Sankyo’s processes.

• Oversees and approves the plan to ensure that the information within a DS system is always up to date with the information in the relevant source system.

• Meets with CRO counterparts to ensure timeliness, quality, and maintenance of data.

• Establishes and maintains CRO/Vendor oversight metrics to ensure that the appropriate oversight processes are followed as mandated.

Leadership / Collaboration:

• Collaborates with other team members to work in a harmonized fashion across areas of specialization to support project and RD objectives.

• Builds and maintains strong relationships with subject matter experts, information technology colleagues, business leads, vendors and external resources in executing projects or other initiatives.

• Through close partnership with the business systems owner, this individual will contribute to the development of the System Roadmaps for assigned systems including current and planned release schedules as well as strategic investment directions.

• This position will be responsible for people management of employees and contract staff and for providing direction of daily activities in support of goals and coaching and mentoring operational team members.

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

Education:

• Bachelor's Degree with 7 years relevant experience required

• Master's Degree MPH with 5 years relevant experience preferred

• PharmD with 3 years relevant experience preferred

• PhD with 3 years relevant experience preferred

Experience:

• 7 or More Years Experience in the pharmaceutical industry with of direct clinical operations and/or managing the operations area and direct interactions with third parties (CROs) experience. preferred

• Possesses a strong knowledge of the drug development processes, relative functional capabilities, and interdependencies preferred

Travel:

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