Director, GCO Program Lead (GCPL)

General Description

Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCO Program Lead is accountable for the strategic operational planning and clinical operational performance, of designated programs and acts as a point of escalation for the resolution of issues of the studies within responsible program(s).

Essential Functions 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 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 preferred 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).
• 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 managing direct reports

Computer Skills

Microsoft Office

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

Travel might be required as per business need.

Education/Experience Required

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

Technical Skills

• Transferrable Skills Across GCO
• Continuous Improvement: Data Analysis, Issue Resolution, Quality Management, Regulatory Compliance, Root Cause Analysis, Schedule Management, Training
• Technical Skills For Program And Study Management
• Computer Operations Management
• Contract Management
• Data Management
• Feasibility Studies
• Project / Program Design
• Project / Program Management
• Risk Management
• Technical Reporting
• Resource Management

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$171,900.00 - $231,900.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.