Executive Director, Global Clinical Operations Study Management Group Head

Job Summary

The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. The teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of projects to plan and to drive standardization and operational excellence across a portfolio of work.

Job Description

Responsibilities

Partner with the VP in developing the functional discipline through (i) functional-area leadership, (ii) keeping abreast with latest functional development in the pharma industry, (iii) supporting consistency, coherence, and compliance, (iv) establishing area-relevant standards, (v) encouraging innovation. Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and execution

Ensure scientific concepts and business priorities are considered to provide strategic global leadership for the clinical operations staff working on clinical programs in scope/portfolio.

Close collaboration with Asset and Portfolio Management (A&PM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization to assess and plan for Ph I – III study team delivery and transitions. This includes engagement with feasibility, CTD, RSEM, and site contracts and budget management.

Ensure delivery of all operational components of global programs within scope, either through external partners (CRO, ARO, etc) or internal delivery models

Act as a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.

Support, where needed, internal program/study review meetings preceding governance investment decision meetings

Provide strategic leadership to drive projects and foster a performance driven global culture

Accountable for the creation of an environment that inspires, motivates, and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the healthcare system.

Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.

Functional leadership of up to 10 employees who manage the delivery Ensure capability build, individual development, and performance management

Accountable for resource management within respective portfolio and collaborating with peers to optimize talent in the organization.

Ensure the GPT GCO reps are functioning at a high and consistent level

Drives a feedback-oriented culture

Responsibilities Continued

Qualifications

Education Qualifications

Bachelor's Degree required

Experience Qualifications

BS/MSA in related discipline, or equivalent work experience required
15+ years industry or related experience required
Extensive early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred
Relevant therapeutic experience and proven ability to learn new indications required
Proven global line management expertise; experience of performance management and development of Director+ level staff required
Proven experience in leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development required
Proven change management experience required
Proven strategic and innovative thinking required
Functional management experience, managing resourcing and budget planning/oversight required
Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required
Demonstrated ability in influencing others in a matrix environment required
Awareness of external competitive environment and operational practices required
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required
Excellent written and verbal communication skills required
Willingness to travel both domestic and international required
Proven ability to develop successful collaborations with internal and external partners required
Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles. required

Travel Requirements

Ability to travel up to 20% of the time. Some domestic and international travel expected

Additional Information