Senior Director, Oncology Laboratory Operations

at  Hologic

Biotheranostics, a Hologic company, develops and provides molecular-based diagnostic, prognostic, and predictive tests that support physicians in the treatment of cancer patients. It serves as the organization’s hub for oncology.
The Senior Director, Laboratory Operations will be responsible for leading and expanding the functions and infrastructure of the clinical lab to manage increased test volume and to provide increased testing capabilities we drive growth.
They are also responsible for building an engaged and performance-oriented culture and team, with a focus on effectively serving our patients.
This is a full-time San Diego office-based position.

• Developing and implementing a strategic plan to industrialize operations to align with growing commercial demand, including the design and execution of validation testing to guarantee robust processes.
• Managing the financial performance of the laboratory, including budgeting and planning for all clinical lab departments.
• Identifying and implementing the appropriate strategies for reducing costs and improving the quality of services
• Assessing laboratory unit operations considering corporate strategies, the Company’s Corporate Compliance Program, and identifying and implemeting operational improvements.
• Defining and coaching teams to the achievement of Corporate and Laboratory Operations Goals
• Developing and implementing Standard Operating Procedures in the clinical laboratory.
• Planning and oversight of CLIA lab facility expansions.
• Leading the clinical laboratory team, including recruitment, retention, training and development, performance management, employee relations, and the development of team-oriented culture within and between departments.
• Partnering with the laboratory personnel to ensure adherence to established procedures and quality checks for all phases of testing, including the pre-analytic, analytic, and post-analytic phases of testing as well as general laboratory systems.
• Partnering with Regulatory and Quality Assurance personnel to execute and maintain a Quality Management System (QMS) compliant with CLIA regulations (42CFR493), College of American Pathologists (CAP) checklists, and applicable state and federal regulations).
• Partnering with the Laboratory Management to ensure policies and procedures are established for hiring and monitoring individuals who conduct testing to assure they have the appropriate education and experience, are competent, and maintain their competency to perform the testing procedures.
• Troubleshooting problems as they affect clinical operations.
• Working with laboratory staff, client services, sales representatives, vendors, and clients to resolve operational or technical issues.
• Acting as primary liaison between lab departments and other departments within the company.
• Serving on various committees including the Corporate Compliance Committee.
• Working with the quality team to compile and analyze trending and statistical reports for the clinical lab to present to management. Participating in the strategic planning process.
• Prepare for and lead the transition into the FDA oversight of Lab Developed tests.
• Oversee implementation of IT initiatives including LIS implementation and EHR integration.