Associate Director / Director, GCO Clinical Program Lead (GCPL)

of the Job:

Strategic leadership and management

• Accountable and responsible for building, developing and retaining the global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management.
• Oversee the delivery and goal achievement of projects within the designated program(s), serving as the point of escalation for resolving issues that gCSM cannot resolve.
• Collaborate with the other GCPLs and Franchise Heads (FH) to define and implement strategies and key priorities across-programs, and establish global standards for goals, performance measures, and capability development for the gCSM roles.

GCO Representative for the designated program(s)

• In coordination with Franchise Head, Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the program strategy and ensure excellence in execution.
• Lead/participate in the KOL engagement activities in the designated programs and may act as function spokesperson if needed.

Program Management

• Evaluate and develop strategic feasibility and budget estimates during Early Planning for new CDPs and upon strategy change during the conduct of a study, where needed.
• Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from early planning to the gCSM.
• Create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant DCT goals for the program.
• Create, review, and provide input to and maintain compound-level documents such as IB, DSUR, and protocol.
• Oversee timely, quality, and efficient study planning and execution of associated studies within the allocated program.
• Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to the DCT/DRC-approved budget and timeline.
• Report on study status, goals, and operational KPIs, and enforce quality KPIs with support from the Compliance team.
• Collaborate with other GCPLs to evaluate and designate

• global vendors and participate in vendor governance meetings.
• Create or review performance and development plans for direct reports, facilitate and support delivery of performance and development goals.
• Provide line management and mentorship to gCSMs working within the designated program(s).
• Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function.
• Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization.
• Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.
• Point of escalation for all compound-related issues.
• Identify and drive process improvement initiatives in collaboration with Franchise Head and/or other GCPLs within program.
• Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals.

Supervisory Responsibilities: Line-manages direct reports of Global Clinical Study Managers (gCSMs).

Education Required:

Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ experience in clinical trial industry.

Computer Skills:  MS Office; Project Planning Applications; Clinical Trial Management Systems (CTMS)

Other Qualifications:

• Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment. Experience in both people management and program management preferred.

Travel: Up to 20%. Ability to travel domestically and internationally.