Associate Director, Clinical Process Management

Location
Basking Ridge, New Jersey, United States
Posted
Oct 21, 2020
Ref
10399BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
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. 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, Clinical Process Management, will partner with functional leaders and process owners to shape and execute a continuous improvement plan for end-to-end clinical trial processes. This includes monitoring process metrics, identifying areas for improvement, designing and implementing process improvements, and leading process improvement teams.

Responsibilities:

Partners with functional leaders and process owners to design and implement a clear, well-defined process with clear inputs, outputs, and roles & responsibilities - integrates people, process, and technology components of process design

Leads cross-functional process improvement teams/workstreams tasked with re-designing or improving processes including establishing timeline for process improvement projects

Develops process maps and other process documentation to facilitate the team's analysis and optimization of processes

Assists Process Owner with change management and implementation of process improvements

Keep Global R&D SOP Office and other relevant SOP committees informed of new processes or process updates requiring SOP updates. Reviews SOPs and training documentation resulting from these new processes or process improvements

Monitor key metrics/KPIs/KCIs and partners with Process Owner to identify and address gaps/deficiencies
Leads cross-functional process improvement teams/workstreams tasked with re-designing or improving processes including establishing timeline for process improvement projects

Work with Process Owners to develop process optimization plans and priorities for review by Process Sponsors and Process Council. Facilitate periodic Process Council review and prioritization of process optimization plans within and across process groups

Works with CRO Alliance Managers and CRO partners to ensure optimization of key process interfaces to ensure seamless integration of internal and external activities

Works with Process Owner to capture and communicate Lessons Learned

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

Education/Experience:

Bachelor's Degree with minimum of 8 years of experience (5 years with PharmD/PhD) in pharmaceutical or biotechnology drug development
  • Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management)
  • Strong leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management
  • Experience in clinical trial process design, harmonization/optimization, and implementation
  • Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements
  • Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable

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.

Job Title
Associate Director, Clinical Process Management

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey