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Lighthouse Lab Services is partnered with a premier, CAP accredited healthcare technology company that helps providers make better treatment decisions when prescribing drugs within their current workflow through genetic testing and clinical decision support. 

Our client's pharmacogenomics (PGx) solution combines a patient’s genetic profile and medical history with a curated clinical database backed by Mayo Clinic’s proprietary knowledge to produce an interactive report that easily integrates into current practices. 

RESPONSIBILITIES: 

  • Review and final approval of appropriate policies and procedures for the laboratory to ensure strict regulatory adherence. 

  • Review and final approval of the QMS, PT, and QC programs within the laboratory; including periodic assessment of the QM plan as well as implementation of CAPA within the laboratory in conjunction with laboratory staff and delegees. 

  • Review and final approval for all new laboratory SOPs, method validations/verification studies, laboratory reporting process. 

  • Meets qualifications to serve as the clinical and technical consultant for the laboratory under CLIA guidelines, and delegates these responsibilities to qualified laboratory staff when appropriate. 

  • Maintains final responsibility for the test system in place, and subsequent release of patient results through an automated, or semi-automated system validated by the laboratory and approved by the Laboratory Director. 

  • Must be available to the laboratory staff as needed, by way of telephone, electronic, and/or on-site consultation. 

  • Liaises with physicians, providers, and on occasion, patients to discuss clinical utility, medical and interpretation; consults with other healthcare professionals as required. 

  • Offers leadership insight into PGx market and guides go-to-market strategies and represents the company during conferences or commercial engagements. 

  • Excellent attention to detail, effective communication skills, and the ability to work both independently and within a team environment. 

  • Authors white papers, publications, and other materials as necessary. 

EXPERIENCE REQUIREMENTS: 

  • Minimum of 3 years of post-professional degree experience, with at least 1 year of experience working in a high-complexity CAP-accredited, CLIA lab. 

  • Experience running, validating, and clinical reporting of PCR-based laboratory developed genetic tests. 

  • Ability to work in a small start-up environment at a fast pace, interacting across multiple disciplines and geographies. 

  • Willing to delegate laboratory responsibilities as appropriate. 

  • Exceptional presentation skills and oral/written communication skills. 

  • Prior experience serving as a Laboratory Director with experience delegating duties to qualified laboratory staff. 

  • Experience with NYSDOH and CAP accreditation process. 

  • Extensive knowledge of Pharmacogenomic genotyping, haplotyping and phenotyping and clinical utility of drug treatments based on evolving literature and guidelines. 

  • Working knowledge and/or hands on experience with clinical test submissions through the FDA 510K process. 

  • Prior experience with “dry laboratory” CLIA testing and analytical services. 

EDUCATION & CERTIFICATION REQUIREMENTS: 
  
The qualified candidate will possess a doctoral degree (MD/DO/PhD) and one of the below listed board certifications. Preference will be given to those who also are eligible to obtain or currently hold a New York Certificate of Qualification in Genetic Testing.   
 
For PhDs: 

  • ABB HCLD –American Board of Bioanalysis with significant Genetics/Molecular experience 
  • ABCC – American Board of Clinical Chemistry in Molecular Diagnostics 
  • ABMM  – American Board of Medical Microbiology with significant Genetics/Molecular experience 
  • ABMGG – American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG) 

For MDs: 

  • ABP—American Board of Pathology in Clinical Pathology or Molecular Genetic Pathology 

  • Current unrestricted Minnesota Medical License 

Salary:  

  • $225,000+ dependent upon experience  

  • Full Benefits 

  • Relocation Assistance 

 

About Us: 

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 16 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories. 

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities. 

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com 

#ABT Job #13466 

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