Senior Director, Laboratory Operations and Site Head (Finance)

About the Job

The Site Head and Senior Director of Laboratory Operations leads operations within FMI's high-volume Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory focusing on the delivery of Next Generation Sequencing (NGS)-based liquid biopsy results for oncology patients.

The Site Head co-leads a cross-functional leadership team to define site priorities, community relations and communications.

This is a regulated position and, as such, supplementary information may be available regarding the regulatory qualifications for this role.

Regular onsite work at a designated FMI location is an essential function of the role.

Key Responsibilities

• Serve as the CLIA Laboratory Director and provide oversight of the clinical molecular diagnostic laboratory NGS-based liquid biopsy testing for oncology patients.
• Direct the activities of laboratory team members to ensure day-to-day operations are in compliance with internal policies, procedures, and CLIA/CAP/FDA regulatory standards.
• Ensure achievement of Key Performance Indicators and generate dashboards/reports summarizing productivity and process performance for presentation to senior leadership.
• Deploy problem-solving skills to assess and identify areas for process improvement and to solve for complex business challenges, including with the review and sign out of clinical test reports.
• Manage the talent pipeline to execute the laboratory operations staffing plan and create effective leadership succession.
• Ensure staffing of the clinical laboratory with appropriately credentialed technical and professional employees.
• Build strong relationships with R&D, Commercial, Client Services, IT, and other standing functions on site to ensure collaboration.
• Monitor site and keep team motivated to reduce attrition.
• Participate in oversight for quality control and quality assurance for existing and new tests, including proficiency testing.
• Establish, monitor and publish service metrics for customer satisfaction and business goals.
• Provide timely responses and support for customer requests, resolution of complaints, investigation into and resolution of laboratory test issues.
• Maintain expertise over company Standard Operating Procedures (SOPs), practices, and applicable professional, federal, state, and local regulations, and assure that the laboratory is in compliance.
• Advise senior leaders on complex technology issues and on optimizing business practices.
• Author, contribute to, and review standard operating procedures (SOPs), tracking forms, training logs, change controls, non-conformance reports and investigations, and deviations or CAPA reports, as needed to support operational excellence.
• Maintain knowledge base of relevant fields and techniques and educate laboratory operations team members on the same.
• Attend scientific conferences and represent FMI externally to commercial and academic partners through talks, tutorials, and publications.
• Represent the Lab Operations department to other sites and divisions for cross-site collaborations, projects and implementation of best practices.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Master's Degree in Biological, Chemical, Physical, or Life Science
• 12+ years of relevant molecular lab experience, site head experience preferred
• 8+ years of prior work in a leadership / management role

Preferred Qualifications

• Experience:
  • Working in a high-volume reference laboratory environments, preferably with a focus on oncology diagnostics
  • Working with Laboratory Information Management Systems (LIMS) and leading projects and process improvements in a professional setting
  • Working in a FDA regulated environment
  • With oncology liquid biopsy testing and diagnostics
  • Mentoring and developing staff at all levels
  • Setting, monitoring, and publishing results on quality, service, and cost goals
• Current Certificate of Qualification in Genetic Testing from the New York State Department of Health Clinical Laboratory Evaluation Program
• Certification or eligibility for:
  • American Board of Medical Genetics and Genomics in Molecular Genetics;
  • American Board of Pediatrics in Molecular Genetic Pathology; or
  • Equivalent doctoral-level board certification
• In-depth understanding of policies, processes, and procedures necessary to perform high quality, high-complexity laboratory testing in environments regulated by CLIA and the Food and Drug Administration (FDA), as well as to deliver these services to physician customers
• Knowledge of quality systems and ability to evaluate laboratory performance, formulate remedial action plans, and evaluate random and systematic errors as needed
• Proficiency utilizing Microsoft Office Suite, especially Excel and Power Point
• Ability to:
  • Communicate effectively, to provide information to senior management on the implication of policies and procedures, and to recommend specific actions
  • Maintain the clinical laboratory at a level of inspection readiness
  • Set, monitor and publish results on quality, service, and cost goals
  • Bring innovative thinking and ideas to solve problems and improve any and all phases of laboratory operations
  • Collaborate with peers in a fast-paced and cross-functional, results-oriented team environment
  • Work within tight timelines for successful and timely execution of project and program goals
• Excellent leadership, human relations and communication skills
• High attention to detail and the ability to adapt rapidly to changing priorities and tasks
• Strong acumen for program management and process improvement
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement . If you have a disability or special need that requires accommodation, please let us know by completing this form . (EOE/AAP Employer)