Senior Director, Clinical, CLD Operations

Responsibilities

• CLD of record for all clinical laboratory licenses.
• Manages other CLDs, and ensures appropriate and timely cross-functional support from the CLD team to the rest of the CLO team as needed and requested: Compliance/Quality, Clinical and Technical functions within CLO and applicable to CLIA, CAP, CLEP regulations.
• Manages the Technical Production group that provides RUO data QC, assay health assessments and related technical troubleshooting and support to the CLDs, VP MLO/Head Clinical Laboratory Director, and CLO function as a whole.
• Develops deep system and function knowledge for assay data QC and clinical reporting activities.
• Collaborates with the Laboratory Operations Staff and clinical services to ensure timely 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 laboratory and provides consults to ordering physicians, leverages team to cover consults for all assays in clinical production.
• Supports, and coordinates schedules for daily clinical data QC to ensure needed coverage.
• Manages clinical reporting activities and capacity planning for the group to ensure staffing levels 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 related projects 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 the company and is recognized as a functional expert for the Clinical Laboratory 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 decisions, review and approval of analytical and clinical studies.
• Ensures inspection readiness and proactively address quality and compliance issues by performing periodic internal audits of the CLO lab for CLIA/CAP/CLEP compliance.
• Serves as a liaison for Adaptive during inspection by external agencies and pharma partners.
• Collaborates closely with senior leaders to provide cohesive direction towards company and CLO goals and supports company strategy both internally and externally.
• Able to navigate complex situations and problems through to resolution, and propose appropriate and compliant solutions.
• Influences the opinions and decision-making of others, including executives and makes appropriate decisions that affect the success 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 continuous improvement initiatives by championing and, when applicable, leading opportunities to improve quality and efficiency for Clinical activities, champions operational improvements to reduce CLD workload.
• Supports LIMS Development in collaboration with the software team (e. g., generates user requirements, UAT cases and plans, completes test plans), reviews and approves related documents for system features and enhancements, as required/requested.
• Author and/or approve documents relevant to the clinical aspects of the CLD role.
• Collaborates with VP MLO, and Head Clinical Laboratory Director to develop and continuously improve day-to-day operations and ensure cross-functional alignment with other CLO groups, as requested.
• Upholds clinical laboratory best practices and complies with applicable regulations.
• Promotes a positive work environment while supporting management and business goals.
• Regulatory responsibilities of “Laboratory Director” for high complexity testing as defined by 42CFR493.1445 and the College of American Pathologist Director Assessment Checklist.
• Regulatory responsibilities (when 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 Laboratory Practices (GLP).

Requirements

• Qualified as a CLIA clinical laboratory director for high-complexity molecular testing
• D. or Ph. D. in a biological science
• ABMGG, ABP, ABB, ABCC or equivalent laboratory director certification in Clinical Molecular Genetics/Pathology
• OR: Qualified as a CLIA clinical consultant with relevant experience in immunology
• D., D. O., or DPM licensed to practice in the State of WA
• 10+ years of experience as a clinical laboratory director in a relevant discipline
• At least 5+ years of experience managing other clinical laboratory directors and/or managers and supervisors
• 2+ years of experience in immunology, or demonstrable working knowledge of human immunology
• Eligible to apply or holds a New York 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 within regulated Gx P laboratory environment
• Ability to collaborate and lead 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.
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