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.

Job Description

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, 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).

People and Resource Management

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

Education Qualifications
Bachelor's Degree in the Sciences preferred

Experience Qualifications
10 or More Years relevant experience required
4 or More Years with a MS/MPH preferred
4 or More Years with PharmD/PhD preferred
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
CRA experience preferred
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred


Travel Requirements
Ability to travel up to 20% of the time. In-house office position that may require some travel (domestic or global).

Physical Requirements
In-house office position that may require some travel (domestic or global). 20% of the time.

Additional Information