Regional Director, Clinical Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Lead, mentor, and nurture Site Directors and Site Managers.

• Establish clear objectives, KPIs, and expectations.

• Step in as Interim Site Director or arrange for coverage during site transitions.

• Oversee site operations and performance metrics to enhance efficiency, quality, enrollment, and adherence to protocols.

• Implement network-wide processes, systems, and SOPs uniformly across all sites.

• Collaborate with site leadership on budgeting, forecasting, FTE planning, and margin management.

• Analyze financial and operational reports to detect risks and trends.

• Work alongside Marketing and Participant Recruitment to enhance enrollment strategies and forecasting.

• Assist Business Development by providing feasibility insights and site capability assessments.

• Collaborate with Quality, Regulatory, and Clinical Affairs to ensure audit readiness and PI oversight.

• Foster relationships with principal investigators and act as the regional escalation point for investigator and sponsor inquiries.

• Assist in hiring, onboarding, and staffing decisions for site-level teams.

• Conduct mid-year and annual performance evaluations for direct reports.

⛳️ Requirements

• Bachelor’s degree in science, nursing, or a related discipline (equivalent combinations of education, experience, and training will be considered).

• 7–10+ years of progressively responsible experience in clinical research or related operations.

• Previous experience managing teams or site operations.

• Preferred 5+ years of experience in people management.

• Clinical experience across two or more therapeutic fields.

• Experience with multi-site networks, SMOs, TMOs, or hospital-owned physician networks is preferred.

• In-depth knowledge of FDA regulations, ICH-GCP, safety reporting, and investigational product handling.

• Background in healthcare with direct patient care and physician collaboration.

• Proficient in making financially sound and defensible business decisions.

• Exceptional communication skills across sites, sponsors, CROs, and regulatory bodies.

• Data-driven individual with a proven record of developing and mentoring talent.

🏝️ Benefits

• 401(k)

• 401(k) matching

• Dental insurance

• Disability insurance

• Employee assistance program

• Flexible spending account

• Health insurance

• Life insurance

• Paid time off

• Vision insurance

• Remote work arrangement

• Up to 50% travel opportunity