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
M.D. with subspecialty board certification in anatomic pathology and molecular genetic pathology (American Board of Pathology)
Minimum 3 years of experience as a surgical pathologist and medical director for a certified clinical laboratory performing histopathologic review and high-complexity testing in the area of molecular diagnostics and/or next-generation sequencing
Demonstrable experience in formal document generation and control related to compliance with clinical testing regulatory agencies (e.g., CLIA, CAP)
Provide identity or work authorization documentation as required for employment verification
Required Skills and Attributes
Detailed knowledge of CLIA and/or CAP regulatory guidelines and inspection preparedness
Advanced knowledge of human genetics including cancer and constitutional disease
Advanced knowledge of nucleic acid-based testing methods, sequencing in particular
Experience-based track record of leadership managing complex situations or serious events involving patient care or safety
Ability to assess complex workflows for efficiency and patient safety
Strong interpersonal and organizational skills
Strong understanding of NGS bioinformatics, cloud computing, data handling
Strong knowledge of anatomic pathology and associated techniques
Proficiency (expert) in English language-based communications
Anticipated % Travel for conferences, meetings, and product development
Additional Salary Information: Compensation package commensurate with experience
PierianDx enables health systems, academic medical centers and commercial labs to deliver patient-specific diagnosis and treatments based on an individual’s DNA. In use since 2011, and regularly enhanced with new patient, clinical and research data, PierianDx’s proprietary Clinical Genomicist Workspace (CGW) provides clinical labs more streamlined and accurate analysis, interpretation, and reporti...ng needed to accelerate their personalized medicine programs. PierianDx also recently launched the NGS Gateway Program, a CAP-accredited, CLIA-certified lab that complements PierianDx partners’ in-house NGS testing services. Clinical Genomicist Workspace™ is a trademark of PierianDx, Inc.