Director, Clinical Business Operatinos

ESSENTIAL JOB FUNCTIONS:

The Director, Clinical Business Operations is responsible for leading strategic and operational initiatives that enable the efficient execution Clinical Operations activities. This role serves as a key business partner across Clinical Trial Management, Clinical Data Sciences, Clinical Systems, Biosample Operations, and other cross-functional team members to drive operational excellence, portfolio visibility, resource planning, performance measurement, and process optimization.

The Director will establish and maintain business processes, operational metrics, governance frameworks, and reporting capabilities that support informed decision-making and execution of the clinical portfolio. This individual will work closely with Clinical Operations leadership to identify risks, improve organizational effectiveness, and ensure alignment between strategic objectives and operational execution. Clinical Operations Leads remain accountable for program strategy and operational execution while Clinical Business Operations provides department-wide planning, governance, reporting, systems, and business infrastructure.

This is an exciting opportunity for a seasoned Clinical Operations leader who has mastered clinical study management and wants to make the leap to a clinical business excellence role.

Strategic Planning & Governance

• Support annual and long-range strategic planning activities for the Clinical Operations organization.
• Coordinate portfolio governance processes and facilitate leadership review meetings.
• Develop and maintain business operating rhythms, including leadership team meetings, performance reviews, and planning cycles.
• Drive cross-functional initiatives aligned with departmental and corporate objectives.

Operational Excellence

• Lead continuous improvement initiatives focused on quality, efficiency, scalability, and execution excellence.
• Develop and implement standardized business processes across Clinical Operations functions.
• Identify operational bottlenecks and recommend solutions to improve performance and organizational effectiveness.
• Partner with stakeholders to ensure successful implementation of process and organizational changes.

Metrics & Performance Management

• Establish and maintain key performance indicators (KPIs) and operational dashboards.
• Deliver meaningful portfolio and departmental performance reporting to leadership.
• Analyze trends and identify opportunities to improve study execution, organizational performance, and resource utilization.
• Support development of executive-level presentations and business reviews.

Resource Planning & Financial Oversight

• Coordinate resource forecasting and capacity planning activities across Clinical Operations functions.
• Partner with Clinical Operations Leads, Finance and functional leaders to support budget planning and tracking.

Systems & Business Enablement

• Provide functional business ownership for systems spanning multiple functions (e.g., eTMF and CTMS) and partner with Clinical Systems and Technology teams to optimize tools, platforms, and business processes.
• Drive adoption of systems and technologies that enhance operational effectiveness.
• Ensure data integrity and consistency across operational platforms.

Leadership

• Manage and develop clinical trial associates and business operations staff as applicable.
• Foster a culture of accountability, collaboration, innovation, and continuous improvement.
• Influence cross-functional teams without direct authority to achieve organizational goals.
• Complete other duties as assigned by the manager

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• A minimum of 10-12 years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing clinical operations activities.
• Foundational skills in financial and resource planning, and business management acumen.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent communication and presentation skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Flexibility to travel domestically and internationally as required.
• Owns decision-making for their functional area or program, including resolving complex issues and making trade-offs to achieve program objectives, with minimal escalation.
• Leads cross-functional collaboration for assigned programs, proactively driving alignment across stakeholders and resolving issues to support program execution.

The base range for this role is $231,000 - $264,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

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