Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company with a rich history of innovation and excellence in drug development. With its U. S. headquarters in Basking Ridge, New Jersey, the company focuses on marketing, medical affairs, sales operations, and clinical trial support. Daiichi Sankyo is dedicated to groundbreaking science and fostering a culture of learning and growth, providing comprehensive healthcare benefits and extensive training and education resources. As an industry leader, their commitment is reflected in their approach to employee development and inclusion.
Daiichi Sankyo • Inc. is a member of the Daiichi Sankyo group of companies and is focused on the development of oncology therapies and specialty medicines. • Oncology • Specialty Medicine
Associate Director - IRT Center of Excellence
March 22
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company with a rich history of innovation and excellence in drug development. With its U. S. headquarters in Basking Ridge, New Jersey, the company focuses on marketing, medical affairs, sales operations, and clinical trial support. Daiichi Sankyo is dedicated to groundbreaking science and fostering a culture of learning and growth, providing comprehensive healthcare benefits and extensive training and education resources. As an industry leader, their commitment is reflected in their approach to employee development and inclusion.
Daiichi Sankyo • Inc. is a member of the Daiichi Sankyo group of companies and is focused on the development of oncology therapies and specialty medicines. • Oncology • Specialty Medicine
📋 Description
• Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. • Provide input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials; • Manage and contribute 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; • Support transparency in operational planning through tracking IRT-related milestones and dashboard inputs; • Ensure 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.
🎯 Requirements
• 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.
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🇺🇸 United States – Remote
💵 $134.9k - $187k / year
💰 $125M Post-IPO Debt on 2022-11
⏰ Full Time
🟠 Senior
👔 Director
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