Director Clinical Trial Risk Management

Location
Basking Ridge, New Jersey
Posted
Jun 30, 2021
Ref
10935BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
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. 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

This position provides strategic direction for and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements to achieve a Quality by Design and Quality Risk Management approach to clinical trial processes and procedures.

Responsibilities
  • RBQM Vision and Strategy: Provides strategy and leads implementation of vision for risk based quality management within impacted Daiichi Sankyo functions globally and with external parties as required.
    • Champions the ‘Quality by Design’ and Quality Risk Management approaches to quality management within Daiichi Sankyo and works to develop a culture that supports these approaches.
    • Create and implement vision for Daiichi Sankyo RBQM future state including operating model, processes, resource requirements, and supportive technology (as needed).
    • Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
    • Aligns the Clinical Risk Manager resources to meet the needs for assisting with the development and implementation of that vision and ensure adequate resourcing for Daiichi Sankyo portfolio of studies.
    • Monitors external environment and incorporates RBQM industry benchmarking, best practices, and emerging solutions within Daiichi Sankyo.
  • Oversee Development and Implementation of RBQM Standards, Tools and Training
    • Ensure Daiichi Sankyo RBQM practices comply with industry regulations / updates (e.g. new requirements), including conduct of impact assessments and implementation of changes as required.
    • Lead development and maintenance of RBQM standards such as guiding principles, risk, and quality tolerance limit (QTL) libraries.
    • Lead RBQM Center of Excellence, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.
    • Develop and implement tools to maximize the consistency, effectiveness, and efficiency of the RBQM processes across Daiichi Sankyo compounds with a focus on oversight, lessons learned and inspection readiness.
    • Lead assessment of training needs and ensure delivery of RBQM Training with Learning and Development team members.
    • Lead development and implementation of process improvement initiatives related to RBQM to improve quality and ensure patient safety and data quality and integrity.
    • Establish, measure, analyze and report on RBQM related metrics and present outputs to Leadership and Management to drive RBQM Implementation.
  • Oversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness.
    • Review and determine acceptability of CRO / vendor RBQM practices and associated tools with Daiichi Sankyo standards.
    • Participate in CRO / vendor governance, ensure oversight of provider RBQM processes and tools and work collaboratively with partners to develop RBQM approaches.
    • Act as issue escalation point for study teams and clinical risk managers related to RBQM and ensure timely and thorough problem resolution as required.

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 in chemistry, biology, pharmacy, or other scientific discipline required

Experience Qualifications
  • 10 or More Years of related pharmaceutical industry or Clinical Research Organization experience preferred
  • 4 or More Years monitoring experience and advanced knowledge of risk based quality management (e.g. Quality by Design principles; Quality Risk Identification and Management processes; root cause analysis; process mapping; etc.). preferred

Travel
Ability to travel up to 10% In-house office position that may require occasional travel (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.