Associate Clinical Laboratory Director (ADX-120-18)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Oversee CLIA certification and CAP accreditation maintenance activities required to support a clinical sequencing service
- Interact with external regulatory agencies, committees, and auditors
- Ensure facility maintains compliance with applicable federal, state, and local regulations
- Direct and manage clinical laboratory operations, including laboratory staff, equipment, and methods.
- Provide oversight for quality control and quality assurance as appropriate, including establishing quality standards for new tests and procedures
- Review, interpret, and report patient results reliably, accurately, and with integrity
- Interact collaboratively with other departments, laboratory staff, and external partners
- Participate in new test development and validation
- Design experiments and analyze and interpret results in both research and development and production environments
- Review scientific literature and attend scientific meetings
- Review and sign-out clinical cases
- Ph.D. or MD with FACMG or ABMGG certification (board-eligible candidates are acceptable)
- Must qualify as a Laboratory Director as promulgated by CLIA 42 CFR 493.1443: Standard; Laboratory director qualifications.
- Experience with clinical next-generation sequencing (NGS) technologies
- Experience with obtaining and/or maintaining CLIA certification and CAP accreditation
- Strong background in human molecular genetics
- At least two (2) years of experience in a laboratory environment with NGS focus, industry preferred.
- Excellent professional communication skills, including verbal, written, and presentation
- Experience working with big data (e.g. omics)
- Strong organizational and interpersonal skills
- Demonstrated strategic, and proactive thinking skills; able to make and support decisions
- Ability to prioritize work, meet deadlines, and be meticulous
- Excellent collaboration skills, with the ability to positively influence others.
- Strong scientific and analytical skills.