The Laboratory Director is responsible for the overall operation, leadership, direction and administration of the Immunology Laboratory of Advanced Diagnostic Laboratories in accordance with Federal and State Regulations governing clinical laboratories. The successful candidate will provide excellent laboratory services to internal clients, referral customers, and industry clients working with the Executive Director, Associate Executive Director, the Business Development Director, Director of Quality, and the other individual Laboratory Directors on issues related to the overall advancements of the Advanced Diagnostic Laboratories.
1. Drives the development and/or clinical validation of new assays that support unmet clinical needs in the field as well as the revenue and strategic goals of National Jewish Health. Works with the National Jewish Health clinicians, research and Advanced Diagnostic Laboratories project managers to assure that new test development occurs in a timely manner consistent with industry standards and client contractual obligations.
2. Works with industry, i.e. pharma, biotech, device and diagnostic developers, and provides diagnostics support for drug development and companion diagnostics applications. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as vendors (contract research organizations, reference laboratories, etc.), clinical investigators, regulatory authorities, professional and public health organizations, key opinion leaders, and advisory boards related to Immunology programs. The Laboratory Director works with other companies, academic/research centers and other entities involved in developing cutting edge biomarkers.
3. Works collaboratively with academic and industry colleagues to identify new diagnostic markers, and with clinical faculty to help define the clinical requirements to assist and lead new Laboratory Developed Test (LDT) and In Vitro Diagnostic (IVD) product development. The Laboratory Director leads activities to identify opportunities for Immunology in human disease diagnostics, and improve current approaches to clinical diseases screening, diagnosis, prognosis, and management core to the clinical expertise of National Jewish Health. Poster presentations and publications as a result of new assay development are an essential part of marketing the laboratory and its capabilities.
4. Promotes the Immunology Laboratory capabilities to the referral testing market, including clinical leaders in immunologic disease, as well as national referral laboratories, hospital networks, local hospitals, clinics, assisted living, veterinary medicine, and public and occupational health needs. Works with marketing and business development to continue the branding and reputation established as an international center of excellence for esoteric Immunology testing. Presenting posters, seminars, and case studies related to the work performed in the laboratories at client visits as well as regional and national conferences is expected. Existing and new clients include Quest, LabCorp, ARUP, Veterans Administration, Sisters of Charity Leavenworth, Kaiser Permanente, stand-alone specialty immunology clinics, and regional health networks.
5. Continuously maintains all quality and regulatory standards for CAP, CLIA, ISO 15189, New York State and other states (as applicable), and other outside client requirements. Responds promptly to any quality audit findings. The Immunology Laboratory Director is a leader with the Quality Management team during regulatory and client audits.
6. Manages laboratory to the expense and net margin targets established and approved by National Jewish Health senior management team for the laboratory's annual performance. Reviews monthly productivity metrics and value stream maps (dashboards) for activities in the laboratories, utilizing the data to drive improvements.
7. Responds to new business development opportunities presented by the Director of Business Development or Executive Director. Works collaboratively with the Business Development Director to identify and deliver new product opportunities, clients, or contractual opportunities.
8. Participates in strategic and tactical planning for Advanced Diagnostic Laboratories, as requested by the Executive Director, including but not limited to new assay development, new testing algorithms, and forecasting personnel staffing requirements, operational expenses, capital equipment, IT/software needs, and training requirements.
9. Ensures that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytical, analytical, and post-analytical phases of testing.
10. Sponsored studies may include the development of a biomarker specific Study Report for drug, vehicle and vaccine safety and/or efficacy from preclinical through phase 3 or comparator clinical studies. These reports are developed, reviewed and finalized through direct collaboration with the sponsor or CRO's nonclinical and clinical scientists.
11. The Laboratory Director works together with Account Managers, Business Development and Client Services to establish and maintain lines of communications with internal and external customers in order to ensure a timely response to new and existing clinical service trends and program planning.
1. Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
2. Building Strategic Relationships: Identifying opportunities and taking action to build strategic relationships between one’s area and other areas, teams, departments, units, or organizations to help achieve business goals.
3. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using one’s understanding of major business functions, industry trends, and own organization’s position to contribute to effective business strategies and tactics.
4. Creativity and Innovation: Applies creative problem-solving skills to develop solutions to problems; recognizes and demonstrates the value in taking "smart" risks and learning from mistakes; develops multiple alternatives and understands the feasibility of each; effectively shares and implements his/her ideas. Generates innovative solutions in work situations; tries different and novel ways to deal with work problems and opportunities.
5. Customer Focus: Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers’ and own organization’s needs.
6. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
7. Initiative: Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
8. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don’t have to.
9. Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
Supervisory or Managerial Responsibility
The Laboratory Director will be responsible for the performance of the Immunology and Beryllium Laboratory and results generated. Direct supervision of staff, including PhD level scientist and Laboratory Supervisor is expected. Other direct reports may be added.
10 to 15% of time
1. Be available to work as scheduled and report to work on time.
2. Be willing to accept supervision and work well with others.
3. Be well groomed, appropriately for your role and wear ID Badge visibly.
4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
7. Wears appropriate PPE as outlined by the infection control policies and procedures.
8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.
MD or PhD in Immunology required
At least 10 years post-fellowship experience working in Immunology. Track record of successful commercial assay development and leadership responsibilities of at least 3 to 5 years required. Experience working with Contract Research Organizations and drug or vaccine product development in drug safety is preferred.
Special Training, Certification or Licensure
Board eligibility or board certification by the American Board of Medical Laboratory in Immunology preferred, or similar certification with specialty training in immunology. The successful candidate is required within one year to obtain a New York Certificate of Qualification as laboratory director in the appropriate categories.