Senior Director, Clinical, CLD Operations

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

📋 Description

• Serve as the Clinical Laboratory Director (CLD) for all clinical laboratory licenses.

• Oversee other CLDs, ensuring timely and appropriate cross-functional support from the CLD team to the broader Clinical Laboratory Operations (CLO) team as required: including Compliance/Quality, Clinical, and Technical functions in accordance with CLIA, CAP, and CLEP regulations.

• Lead the Technical Production group responsible for providing QC data for RUO, assessing assay health, and offering technical troubleshooting and support to the CLDs, VP MLO/Head Clinical Laboratory Director, and the CLO function overall.

• Cultivate in-depth knowledge of systems and functions related to assay data QC and clinical reporting activities.

• Collaborate with Laboratory Operations Staff and clinical services to guarantee timely and accurate reporting of results.

• Actively develop and share dashboards that indicate status and alerts concerning clinical diagnostic turnaround and Clinical and technical functions.

• Enhance clinical understanding of assays in the production laboratory and provide consultations to ordering physicians, utilizing the team to cover consultations for all assays in clinical production.

• Support and coordinate daily clinical data QC schedules to ensure adequate coverage.

• Oversee clinical reporting activities and capacity planning for the group to ensure appropriate staffing levels meet projected needs.

• Recruit, onboard, mentor, train, and retain skilled staff to fulfill the strategic and tactical needs of the group and the organization.

• Manage personal and team time effectively, delegate tasks, and monitor work and related projects to ensure efficient and timely delivery according to established timelines.

• Foster strong working relationships with the Medical Affairs team, Clinical Services, and others as needed to effectively support Clinical team requirements.

• Act as a trusted advisor throughout the organization and be recognized as a functional expert for the Clinical Laboratory Director team.

• Represent CLD functions on product development teams as necessary, utilizing the team to support activities such as clinical report content and approval, clinical data QC and reporting software requirements, input and approval for key assay design and process requirements, and review and approval of analytical and clinical studies.

• Ensure readiness for inspections and proactively address quality and compliance issues by conducting regular internal audits of the CLO lab for CLIA/CAP/CLEP compliance.

• Serve as a liaison for Adaptive during inspections by external agencies and pharmaceutical partners.

• Work closely with senior leaders to provide unified direction towards company and CLO goals, supporting company strategy both internally and externally.

• Navigate complex situations and challenges to resolution, proposing appropriate and compliant solutions.

• Influence the opinions and decision-making processes of others, including executives, making decisions that impact the success of the CLD team and the CLO as a whole.

• Collaborate cross-functionally with relevant teams to optimize resource utilization, build essential relationships, and ensure effective communication and alignment across functions.

• Contribute to continuous improvement initiatives by leading and championing opportunities to enhance quality and efficiency for Clinical activities, advocating for operational improvements to lessen CLD workload.

• Assist in LIMS Development in coordination with the software team (e.g., generate user requirements, UAT cases and plans, complete test plans), and review and approve related documentation for system features and enhancements as needed.

• Author and/or approve documents pertinent to the clinical aspects of the CLD role.

• Collaborate with VP MLO and Head Clinical Laboratory Director to enhance daily operations and ensure cross-functional alignment with other CLO groups as requested.

• Uphold best practices in the clinical laboratory and comply with applicable regulations.

• Foster a positive work environment while supporting management and business objectives.

• Fulfill regulatory responsibilities of “Laboratory Director” for high complexity testing as defined by 42CFR493.1445 and the College of American Pathologist Director Assessment Checklist.

• Assume regulatory responsibilities (when delegated) as “Technical Supervisor” for high complexity testing as defined by 42CFR493.1451.

• Take on regulatory responsibilities as “Clinical Consultant” for high complexity testing as defined by 42CFR493.1457.

• Adhere to regulatory responsibilities under Good Laboratory Practices (GLP).

⛳️ Requirements

• Must be qualified as a CLIA clinical laboratory director for high-complexity molecular testing.

• Hold a M.D. or Ph.D. in a biological science.

• Possess ABMGG, ABP, ABB, ABCC, or an equivalent laboratory director certification in Clinical Molecular Genetics/Pathology.

• Alternatively, be qualified as a CLIA clinical consultant with relevant experience in immunology.

• Hold a D.O. or DPM license to practice in the State of WA.

• Have 10+ years of experience as a clinical laboratory director in a relevant discipline.

• Possess at least 5+ years of experience managing other clinical laboratory directors and/or managers and supervisors.

• Have 2+ years of experience in immunology or demonstrable working knowledge of human immunology.

• Be eligible to apply for or hold a New York State Certification of Qualification in Oncology (Molecular Cellular Tumor Markers).

• Ability to communicate effectively and operate within a large group setting.

• Exhibit advanced critical thinking and problem-solving capabilities.

• Experience in a regulated GxP laboratory environment.

• Proficient in collaborating and leading cross-functionally.

• Possess a high attention to detail.

• Exhibit excellent organizational and time-management skills.

• Demonstrate superior oral and written communication skills.

• Ability to multi-task and thrive in a fast-paced environment.

🏝️ Benefits

• Equity grant

• Bonus eligible