Senior Director, Global Clinical Operations Study Optimization

Daiichi Sankyo • Basking Ridge, NJ

78d • $222,150 - $370,250

About The Position

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.

Requirements

• Bachelor's Degree required.
• 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.

Nice To Haves

• 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.

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.
• 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.
• Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration.
• 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.
• 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.
• 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.
• Drive continuous improvement in Feasibility and Recruitment Planning processes and cycle times.
• 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.
• Ensure trials are designed and conducted with a strong focus on patient diversity, equitable access, and inclusive practices.
• Partner with cross-functional teams to integrate patient insights into study design, protocols, and feasibility assessments.
• Manage a team who creates innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice planning.
• Stay current with regulatory guidance on diversity and inclusion in clinical research.
• Conduct performance evaluations against goals for their direct reports.
• Coach and guide their functional and/or direct reports in support of their development needs.

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• paid_holidays
• paid_volunteer_time
• tuition_reimbursement
• employee_stock_purchase_plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees