Director, Global Clinical Operations

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.   

Job Summary:

Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to colleagues that they are directly line managing in their group. They will ensure their direct reports are meeting required study deliverables including but not limited to oversight of CROs and Vendors and (as applicable) properly leading and ensuring delivery of milestones for the studies within assigned program(s). They are accountable to ensure their direct reports are delivering to agreed upon study plans, properly identifying risks/mitigations, escalating as appropriate and utilizing data and metrics to put appropriate strategies and plans in place as well as measuring the status/variance of a study and putting appropriate measures in place to course correct where needed. The Director will be accountable to support SDL and employee personal development, including routine talent management, offering real time feedback, and mentoring them for success. He/she is responsible to ensure their direct reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead) is fully informed of the overall portfolio status and that any risks are raised, with appropriate mitigations in place. The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject Matter Expert) on applicable Study Managment processes. He/she will work with their management to share lessons learned and best practices across the Study Management Organization. The Director can serve as an SDL at early stages before an SDL is assigned or provide back-up for SDL in the event an SDL is not available. The Director may represent operations as needed/required at GPT and meet with stakeholders to support the larger program or their group of studies. They are expected to foster the growth and credibility of the GCO organization. This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include building and sustaining relationship with key stakeholders to ensure a coordinated and aligned strategy.

Responsibilities:

Operational Strategy and Oversight:

• Align with the Senior Director, Global Clinical Operations on plans for successful implementation of studies. Responsible to ensure the management of assigned assets at the program level through the operational resources assigned to their program. May on occasion represent Global Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their assigned asset(s).

• Provide input into the operational aspects of CDP and individual protocols to facilitate successful implementation of their assigned programs.

• They are responsible to support improving GCO capabilities such as process improvements and support of additional guidance, tools, etc. as necessary.

• CRO/Vendor and Quality Oversight

• Accountable to ensure proper oversight of CROs utilized within their assigned asset. May on occasion represent Global Clinical Operations on the DS/CRO Joint Operating Committee. Ensure their direct reports and operations team in their assets have proper oversight plans in place for all studies falling under their responsibility.

• Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study oversight and execution.

• Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure quality expectations are met.

• Support operations team members on their responsible asset and their direct reports in setting strategies and plans for their teams with the CROs. Responsible to review metrics and issues for their studies and ensure proper attention and mitigations are being applied. Whenever possible, r