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.
Lead end to end feasibility process to ensure successful delivery of global feasibility and country/site selection activities (strategy, plans, timelines, synthesis of feasibility insights, utilization of data-driven approaches, and presentation to study teams) at program/study level. This includes partnering with study management on recruitment strategies, monitoring, and mitigation planning. The scope includes CRO/ARO feasibility support and vetting and future internal delivery. Depending on business needs this position will take leadership and participate of process improvement initiatives that are at the intersection of technology, process and analytics that may directly or indirectly support Feasibility and/or additional related areas (e.g study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.
- Lead data-driven development of study timelines including start-up forecasts and enrollment projections using technology and data analytics
-Provide data-driven operational feasibility strategy, including site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration outstanding needs of indication, patient population, study, and business priorities.
-Collaborate with the Clinical Trial Diversity (CTD) team to incorporate CTD needs in the operational feasibility planning and strategy.
-Maintain the patient enrollment forecast from a strategic perspective. In collaboration with the DS study team and CRO (if applicable), responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g., change in drug landscape, protocol amendment, increased screen failure rate).
-Incorporate data analysis (e.g., local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study.
-Use and incorporate competitive intelligence data to develop data-driven study startup forecasts, benchmarking assumptions, and accurate enrollment plans.
-Partner with study design teams on protocol optimization enabling data-driven approaches to inform decision making and improve predictability of execution
-Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success to ensure maximum impact and efficiency in overall feasibility processes and output. Collaborate effectively with other areas within the business such as IT and RD Excellence as it relates to existing data and KQI/KPIs.
-Ensure technology are relevant are effective, streamlined and are by design initiated at the optimal time in the clinical drug development process.
-Model and implement best, worst, and expected scenarios in partnership with study management to increase transparency on impact to clinical trial operational delivery and costs.
-Lead efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued feasibility and forecasting services
-Apply consistent standards and identify opportunities to effectively scale processes and staff to innovate.
-Stay abreast of relevant industry and consumer changes including the use of specialty vendors (feasibility and data providers) and provide protocol-specific feasibility strategies to key stakeholders.
-Proactively reach out and build relationship with key functional decision makers at clinical development and operational team levels to drive adoption of fit for purpose strategies and tactics to support operational design optimization.
-Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- People management
-Ensure feasibility related roles and responsibilities within external partners (e.g. CROs, specialty Vendors) and internal to Daiichi Sankyo (e.g. Regional Site Engagement Managers) are well defined, clear and aligned
-Oversee, train and mentor employee and/or contractor-based staff/analysts to support the overall end to end feasibility processes and oversight, and timely and consistent data and insight package development.
-Drives a feedback-oriented culture
-Manage performance deliverables of team members
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 required
- 7 or More Years 7 + years global clinical operations experience in study feasibility, and/or study design optimization. required
- Proficiency with software models and database structures. preferred
- Expertise in principles driving country/site identification, feasibility and selection strategies. preferred
- Previous experience leading an organization and partnering as well as influencing senior-level management and key stakeholders is a plus. preferred
- Ability to demonstrate, interpret, explain, represent, and drive unbiased data-driven insights into clinical trial operational planning. preferred
- Proven track record of providing feasibility related services and value to organization(s) preferred
- Demonstrated success in working cross-functionally in a global matrix organization 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.