PierianDx is a bioinformatics company in the healthcare sector facilitating clinical genomic testing for a variety of clients. The Medical Director is responsible for achieving and maintaining compliance with all regulatory entities, and thus ensuring safe and high quality clinical testing services. The position oversees all of the workflows for individual testing services, including the competency and performance of technologists and analysts and the quality control monitors active in these workflows. The Medical Director is a direct liaison with clients and regulatory agents for issues related to clinical testing services. These activities will be performed for PierianDx and/or partner laboratories where PierianDx is responsible for providing Medical Director functions.
This position reports to the Chief Medical Officer and/or the Chief Executive Officer. The successful candidate will have experience as a medical director for a clinical high-complexity laboratory performing molecular diagnostics and associated histopathologic review, and preferably including validated assays employing next generation sequencing technology. The position will require excellent organizational and interpersonal communication skills, and the ability to manage multiple parallel personnel and processes efficiently.
- Review, edit, and attest to all documents required for regulatory compliance (CLIA, CAP, and/or specific state agencies)
- Develop, implement and maintain a Quality Management Program that includes quality controls, workflow monitors, assay and analytics validations, proficiency testing and self-inspection program management, process improvement program management, laboratory safety and ergonomics, personnel qualifications and competency, and HIPAA-compliant electronic systems controls
- Professional communications with clients, ordering physicians, partner laboratory personnel, regulatory agency officials, and organization staff and leadership regarding clinical testing services
- Development and implementation of minimum quality standards and attestation (sign-off) for all services requiring a clinical report that minimum quality standards have been achieved
- Coordination with lab operational leadership to anticipate and mitigate problems arising in any production workflow (crisis management)
- Perform histopathologic review of oncology cases submitted for molecular diagnostics
- Estimation and documentation of the percentage and viability of neoplastic cells in the tested sample by an appropriate method (e.g., histomorphology, flow cytometry).
- Archiving a representative slide (or a digital image of the slide) when the specimen consists of a tissue sample. For specimens that require enrichment (e.g., via microdissection, coring), archiving of representative slides of pre- and post-enrichment tissue sections (or digital images).
- Review and interpretation of clinical data including sign-off of clinical patient reports
Associated Non-essential Functions
- Participation in new product development with expertise on validation planning and budgeting
- Collaboration with other PierianDx Network partners and their affiliates in processes that improve PierianDx services or lead to internetwork cooperativity and collaborations
- Participation in production and delivery of presentations that communicate the medical and clinical laboratory mission, accomplishments, scientific and/or clinical publications, and new products and services goals