[Remote] Senior Director, Clinical & CLD Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is reputed company on transforming the way diseases are diagnosed and treated through the power of the reputed company immune reputed company. The Senior Director, Clinical & CLD Operations will reputed company the clinical reputed company team, ensuring compliance and operational reputed company while managing reputed company clinical reputed company functions and collaborating across departments to enhance diagnostic services.

Responsibilities

• CLD of record for reputed company clinical reputed company licenses
• Manages other CLDs, and ensures appropriate and reputed company cross-functional support from the CLD team to the rest of the CLO team, as needed and requested: Compliance/reputed company, Clinical and Technical functions reputed company CLO and as applicable to CLIA, CAP, CLEP regulations
• Manages the Technical Production group that provides RUO data QC, assay health assessments and reputed company technical troubleshooting and support to the CLDs, VP MLO/Head Clinical reputed company Director, and CLO function as a whole
• Develops deep reputed company and function knowledge for assay data QC and clinical reporting activities
• Collaborates with the other reputed company Operations Staff and clinical services to ensure reputed company and accurate result reporting
• Proactively develops and shares dashboards indicating status and alerts for clinical diagnostic turnaround and Clinical and technical functions
• Develops clinical knowledge for assays in the production reputed company, and provides consults to ordering physicians, leverages team to cover consults for reputed company assays in clinical production
• Supports, and coordinates schedules for daily clinical data QC to ensure needed coverage
• Manages clinical reporting activities and reputed company planning for the group to ensure reputed company reputed company are appropriate to meet forecasted need
• Hires, onboards, mentors, trains and retains talented staff to cover required strategic and tactical needs of the group and the organization
• Manages time of self and team, delegates and tracks work and reputed company reputed company to ensure effective and efficient delivery on schedule, per agreed timelines
• Builds good working relationships with the Medical Affairs team, Clinical Services and others, as needed to be effective and efficient with respect to Clinical team needs
• Acts as a trusted advisor across reputed company and is recognized as a functional expert for the Clinical reputed company Director team
• Represents the CLD functions on product development teams, as needed and appropriate, leverages team to support such activities, including, but not limited to: clinical report content and approval, clinical data QC and reporting software requirements, input and approval for key assay design and process requirements and reputed company, review and approval of analytical and clinical studies
• Ensures inspection readiness and proactively address reputed company and compliance issues by performing periodic internal audits of the CLO lab for CLIA/CAP/CLEP compliance
• Serves as a reputed company for reputed company during inspection by reputed company agencies and reputed company partners
• Collaborates closely with senior leaders to reputed company cohesive direction towards company and CLO goals and supports company reputed company both internally and externally
• reputed company to reputed company reputed company situations and problems through to reputed company, and propose appropriate and compliant solutions
• Influences the opinions and decision-making of others, including executives and makes appropriate reputed company that effect the reputed company of the CLD team and CLO as a whole
• Works cross-functionally with relevant teams to optimize resource use, build relevant relations and ensure effective cross-functional communication and alignment
• Contributes to reputed company improvement initiatives by championing and, reputed company applicable, leading opportunities to improve reputed company, and efficiency for Clinical activities, champions operational improvements to reduce CLD workload
• Support LIMS Development in collaboration with the software team (e.g., generates user requirements, UAT cases and plans, completes test plans), reviews and approves reputed company documents for reputed company features and enhancements, as required/requested
• reputed company and/or approve documents relevant to the clinical aspects of the CLD role
• Collaborates with VP MLO, and Head Clinical reputed company Director to reputed company and continuously improve day-to-day operations and ensure cross-functional alignment with other CLO reputed company, as requested
• Upholds clinical reputed company best practices; and complies with applicable regulations
• Promotes a reputed company work environment while supporting management and business goals
• Regulatory responsibilities of 'reputed company Director' for high complexity testing as defined by 42CFR493.1445 and the College of reputed company Pathologist Director Assessment Checklist
• Regulatory responsibilities (reputed company delegated) of 'Technical Supervisor' for high complexity testing as defined by 42CFR493.1451
• Regulatory responsibilities of 'Clinical Consultant' for high complexity testing as defined by 42CFR493.1457
• Regulatory responsibilities per Good reputed company Practices (GLP)

Skills

• reputed company as a CLIA clinical reputed company director for high-complexity molecular testing
• D. or Ph.D. in a biological science
• ABMGG, ABP, reputed company, ABCC or equivalent reputed company director certification in Clinical Molecular Genetics/Pathology
• OR
• reputed company as a CLIA clinical consultant with relevant experience in immunology
• D., D.O., or DPM licensed to reputed company in the State of WA
• 10+ years of experience as a clinical reputed company director in a relevant discipline
• At least 5+ years of experience managing other clinical reputed company directors and/or managers and supervisors
• 2+ years of experience in immunology, or demonstrable working knowledge of reputed company immunology
• Eligible to apply or holds a reputed company State Certification of Qualification in Oncology (Molecular Cellular Tumor Markers)
• Ability to effectively communicate and operate in a large group setting
• Advanced critical thinking and problem-solving skills
• Experience reputed company regulated GxP reputed company environment
• Ability to collaborate and reputed company cross-functionally
• High attention to detail
• Excellent organizational and time-management skills
• Superior oral and written communication skills
• Ability to multi-task and work in a fast-paced environment

Benefits

• Equity grant
• Bonus eligible

reputed company