Senior Director, Global Clinical Operations Study Optimization

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 GCO Senior Director of Study Optimization has accountability for the oversight, management, and leadership of the operational enabling functions including feasibility, functional excellence, recruitment and retention, patient voice and clinical trial diversity. The leader may also strategize and establish future sub functions to support and optimize CRO, ARO, and internal delivery modes. This role will matrix with internal and external stakeholders and ensure successful delivery of the clinical studies.

Responsibilities:

Guide strategy and delivery of GCO Functional Excellence. Shape and implement a continuous process improvement framework for clinical operations ensuring quality and optimal delivery.
Solicit GCO needs, ensure cumulative tracking in place with associated priority, and institute communication plan with GCO LT and organization. Support selected nonclinical (process and/or technology) initiatives with project management and/or appropriate process improvement methodology techniques -Establish and maintain a network of Process Owners for key GCO processes and GCO representation on cross functional processes. When needed, represent GCO for business process workstreams. Support the efforts of Process Owners to drive change management and implementation of major process design changes. Support the evaluation, implementation, and adoption of digital tools and technologies that enhance trial efficiency. Collaboration with GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration. Partner with other functional excellence colleagues, such as clinical development, to ensure harmonization. Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders. Provide strategic leadership to drive projects and foster a performance driven global culture. Accountable for the creation of an environment that inspires, motivates, and empowers colleagues.
Accountable to lead delivery of enterprise activities within study activation activities including feasibility and recruitment planning. Ensure analytics, benchmark driven data, and predictive analytics via AI tools are being employed where possible. Mentor and guide directors in the team to:

Partner with CTBO and PD to monitor performance with goal of cycle time reduction. Ensure CRO feasibility and recruitment plans include competitive trial landscapes, and standard-of-care practices in potential geographies. Utilize machine learning and modeling to analyze historical performance metrics, epidemiology data, and investigator/site capabilities to support selection decisions. Ensure internal/external databases are being leveraged with industry intelligence sources.-Drive continuous improvement in Feasibility and Recruitment Planning processes and cycle times by staying up to date with industry trends, competitor activities, and emerging recruitment/retention strategies.-Implement mitigation plans including trigger points and cost strategies to support study teams.-Close collaboration with Asset and Portfolio Management (APM) and GCO Clinical Trial Business Operations (CTBO) to assess and plan for Ph I – III study level feasibility.
Accountable to ensure trials are designed and conducted with a strong focus on patient diversity, equitable access, and inclusive practices. This will aim to embed patient voices and perspectives throughout the research lifecycle, from study design to recruitment, retention and trial execution.

Partner with cross-functional teams to integrate patient insights into study design, protocols, and feasibility assessments. Ensure recruitment and retention strategies address barriers to participation (e.g., cultural, socioeconomic, geographics, linguistic). Collaborate with data and analytics teams to monitor inclusion metrics and report progress on diversity goals. Manage a team who creates innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice planning. Ensure the Clinical Trial Diversity (CTD) leader designs a delivery framework for diversity plans and patient voice at disease, program, study, country, and site levels. Stay current with regulatory guidance (e.g., FDA, EMA, NIH) on diversity and inclusion in clinical research. Establish best practices, training and resources for internal teams and clinical sites on patient centered trial conduct.

People management:

Conduct performance evaluations against goals for their 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:

• Bachelor's Degree required

Experience:

10 + years global clinical operations experience including organizational leadership and influencing senior-level management required
BS/MS in related discipline, or equivalent work experience required
Extensive early/late-stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent required
Relevant therapeutic experience and proven ability to learn new indications required
Proven global line management expertise; experience of performance management and development of Director+ level staff required
Preferred experience in analytics, AI, feasibility, and CTD preferred
Proven experience in leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development preferred
Proven change management experience preferred
Proven strategic and innovative thinking preferred
Functional management experience, managing resourcing and budget planning/oversight preferred
Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership preferred
Demonstrated ability in influencing others in a matrix environment preferred
Awareness of external competitive environment and operational practices preferred
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment preferred
Excellent written and verbal communication skills preferred
Willingness to travel both domestic and international preferred
Proven ability to develop successful collaborations with internal and external partners preferred
Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles preferred

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.

Salary Range: