Immuno-Oncology Lab Director
The Medical and Clinical Lab Director position is a full time role which consists of a primary clinical laboratory director role as well as cross-over into R&D. You will lead a dynamic clinical laboratory team, genetic counselors, Ph.D. scientists in interpreting and signing out our new NGS based cancer tests. In addition, you will lead efforts to ensure quality and improve those tests and the processes required to perform those tests. Finally you will be interacting with a broader R&D team identifying and developing the next generation of NGS based tests for the growing area of immuno-therapy. Your work will contribute to a new generation of genomics based precision medicine products in immuno-oncology and cancer clinical trials, diagnostics, and therapeutics being used by clinicians, hospitals, pharma, and biotech.
Duties may include but are not necessarily limited to the following
- Lead medical interpretation and sign out for the NGS-based cancer tests, working with an interdisciplinary team of genetic counselors, molecular biologists, bioinformaticians, physicians to interpret clinical cases including variant review, classification, reporting and sign-off.
- Lead team for validating new clinical tests or test modifications, and establishing test performance specifications
- Develop methods for improving accuracy, efficiency and scalability of laboratory process and clinical interpretation processes
- Develop, maintain, and update SOPs for clinical test products
- Oversee proficiency testing activity selection and performance on clinical cancer tests to maintain CLIA/CAP certification
- Participate in quality management system, including monthly Quality Assurance meetings, Safety committee meetings, and other QA/QI activities
- Guide and oversee the quality of our laboratory processes including participation in hiring of personnel and ensuring competency of personnel performing test procedures; recording and reporting test results promptly, accurately and proficiently; and assuring compliance with all applicable regulations.
- Identify and participate in developing new product/assay/test opportunities consistent with the compnay focus on innovation, especially in the area of Immuno-oncology.
- Ensure that the clinical laboratory develops and uses a quality system approach to testing that provides accurate and reliable patient test results, ensuring compliance of pre-analytical, analytical, and post-analytical processes with applicable regulations.
- Publish scientific results, validation studies, and clinical cases
- Represent the organization by presenting at key conferences and over time, meeting with potential customers.
- M.D. with valid California physician license or Ph.D. with active California Laboratory Director permit.
- Board Certification through the American Board of Pathology in Molecular Pathology (preferred), or equivalent board certification through the American Board of Medical Genetics and Genomics
- +5 years of clinical laboratory experience in high-complexity setting
- Experience with clinical NGS-based assays or other clinical laboratory testing in molecular pathology areas
- Experience with CLIA inspections and knowledge of regulatory requirements, experience with NYS DOH accreditation preferred
- Experience leading, growing, and scaling clinical laboratories
- Ability to work independently with a multi-disciplinary team in a resourceful startup