Dir Clinical Operations Non-MD

Job Summary

Job Description

Responsibilities

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.

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, resolve issues that have been escalated or if warranted and as applicable, take issues to the appropriate governance committee.

Ensure proper oversight of the CRO is being completed on their respective studies to ensure compliance with Daiichi Sankyo's quality measures. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.

Support as needed the validation the study implementation plan provided by the CRO through to study close out and CCSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).

Develops talent through providing focused career development, performance management and manages retention.

Fosters a high-quality culture ensuring workload balance, cross functional alignment for roles and responsibilities as well as ensuring communication across lines.

Identifies opportunities to advance the roles within Study Management by looking for ways to add value and create efficiencies.

Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.

This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalf

Responsibilities Continued

Qualifications

Additional Information