About OneOme
We are a precision medicine leader, providing evidence-based pharmacogenomic solutions that facilitate more personalized prescriptions across the globe. Our RightMed solution helps healthcare organizations, providers, and payers optimize patient outcomes and reduce costs by facilitating more personalized prescriptions. Paired with an in-house CLIA-certified, CAP-accredited lab, OneOme’s RightMed test provides powerful genetic insights that doctors, pharmacists, and other healthcare providers can use to help inform medication decisions for their patients. Our mission is to provide the most cost-effective, comprehensive, personalized, pharmacogenomics analysis integrated into patients’ everyday clinical care. OneOme was named one of Fast Company’s 50 Most Innovative Companies of 2018.
Role description
The Laboratory Director will work closely with laboratory staff and other departments at OneOme. This role holds the final responsibility for approving all test systems in place within the laboratory including, but not limited to assay and instrument validation, standard operating procedures, and the final report sign out.
This position requires excellent attention to detail, effective communication skills, and the ability to work both independently and within a team environment.
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 OneOme during conferences or commercial engagements
- Authors white papers, publications, and other materials as necessary
- Other duties and responsibilities may be assigned
Qualifications
- M.D., MD/PhD or PhD degree
- Certification in high complexity molecular testing OR ABMGG certification in molecular genetics or LGG specialties
- Board-certification in high-complexity molecular testing recognized by HHS, CA, and NYSDOH
- 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
Position location
OneOme Headquarters, 807 Broadway St NE, Suite 100, Minneapolis, MN 55413
Remote arrangements will be considered, but onsite time and other travel may be necessary twice per month. You will be required to manage the work effectively as a remote employee.
Schedule and hours
This job is full-time position and work hours may include limited nights or weekends.
The Laboratory Director will be on-site every other week, for at least 30 hours.
Work environment
OSHA RISK FACTOR CATEGORY 1. The employee is regularly required to talk or hear. The employee frequently is required to stand, walk; sit; and use hands to finger, handle, or feel, and work with a computer. The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and smell. The employee must occasionally lift up to 50 pounds and/or carry objects weighing up to 25 pounds. The employee is required to perform repetitive motions, including reaching above the head, and typing. Specific vision abilities required by this job include peripheral vision, depth perception, and ability to adjust focus. Color-blindness testing is required for those with job-specific duties requiring color discrimination.
To apply
If interested, please send your resume and cover letter to careers@oneome.com.