Associate Director, IRT Center of Excellence

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary

This position is responsible for managing Interactive Response Technology (IRT)-related activities across multiple clinical trials and / or at the vendor level according to Good Clinical and Manufacturing Practices (GCP. GMP), and Daiichi Sankyo standard practices. A successful candidate will be responsible for providing subject matter expertise in IRT while driving the development and delivery of IRT systems across global matrixed teams.

Responsibilities

Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. These activities will include:

• Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials;

• Managing and contributing to the IRT system development lifecycle, including requirements gathering, user acceptance testing, issue management, change management and decommissioning activities, to minimize unanticipated impacts across programs and stakeholders;

• Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs;

• Ensuring inspection readiness of IRT-related items for assigned clinical trials.

• Develop and manage the Request for Proposal (RFP) process for new IRT systems.

• Lead Operational Management Team (OMT) responsibilities for assigned IRT vendors.

• Support compliance audits, IRT vendor audits and regulatory inspections.

• Lead and/or contribute to cross-functional and global improvement projects that include IRT-related data and/or IRT vendors.

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 life sciences or medically related field required

• Master's Degree in life sciences or medically related field preferred

Experience Qualifications

• 7 or More Years related experience in life sciences or medically related field including 6 years of supporting pharmaceutical/biopharmaceutical clinical research experience (obtained by working on clinical trials at a pharmaceutical, biopharmaceutical, CRO or relevant vendor) required

• 7 or More Years direct experience leading IRT-related projects with cross-functional stakeholders required

• 4 or More Years direct managerial and/or leadership experience preferred

• Ability to travel up to 10% Single day / overnight / multi-day travel will be required to go to outsourced vendors or company offices.

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.