Manager, Trial Feasibility & Site Identification In Remote At Daiichi Sankyo

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 15,000 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.
 

Summary

Responsible for end-to-end operational feasibility deliverables at the disease, program, study, country, and site levels. This position is required to work within a team focused on process, data/insight packages, outsourcing, and innovation. Depending on business needs this position may take leadership and/or will participate in 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.

Responsibilities:
 

• Execute on end-to-end operational feasibility processes
• Continuously improve end-to-end operational feasibility processes and roles and responsibilities, including oversight of operating model with CRO(s) and any specialty vendors.
• 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.
• Contributes to process related improvement in process space. This includes gathering cross functional feedback to support significant process improvement efforts related to process space.
• Supports design and development of data and insight packages
• Support development and timely delivery of appropriate data and insight packages (with support from other staff members as appropriate) to program and study teams to support all relevant Governance and planning meetings.
• Support engagements with program and study teams to support the build out of various what if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.
• Identify opportunities to effectively scale processes and staff in support of building such data and insight packages.
• Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of fit for purpose strategies and tactics to support operational design optimization.
• Identify innovative approaches, platforms, best practices, tools and data strategies to support best in class feasibility inputs to Daiichi Sankyo’s clinical programs and studies
• Supports technology evaluation to meet feasibility needs, helps run tests and pilot efforts to ensure capabilities work as intended, UAT, etc.
• Provide oversight and be one of the key subject matter experts (SMEs) on Daiichi Sankyo's existing feasibility related portfolio of platforms, tools and systems.

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 5+ years relevant experience is required
• Master's Degree 3+ years relevant experience is required
• PharmD 2+ years relevant experience is required
• PhD 1-year relevant experience is required Experience Qualifications
• 4 or More Years clinical operations experience with strong preference for study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at a global level. Prior investigator site and/or monitoring experience is advantageous
• Proven track record of providing feasibility related services and value to organization(s)
• Demonstrated success in working cross-functionally

Travel: Ability to travel up to 10% Remote by Design. May require some 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.