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Scientific Director - Clinical Chemistry
Ref No.: 20-00131
Category: Biotechnology
Location: Allentown, Pennsylvania
The Scientific Director is responsible for overall diagnostics assay development and new technology assessment in assigned area (Clinical Chemistry). The Scientific Director works under the supervision and guidance of the Clinical Laboratory Director and in conjunction with laboratory operations management, to ensure the effective administration, coordination and communication of all business, technical and Clinical aspects of the laboratory operations. Assists the Clinical Laboratory Director in the technical and quality activities of the laboratory. This individual will also be responsible for recording and reporting test results promptly, accurately and proficiently, and for assuring compliance with all applicable regulations.  
 
The purpose of this document is to describe the general nature and level of work performed by personnel as classified; it is not intended to serve as an inclusive list of all responsibility associated with this position.
 
RESPONSIBILITIES:
  • Designs, implements and directs development of assays critical to corporate strategies and client requirements.
  • Selects test methodology that is appropriate for the clinical use of the test results.
  • Investigates and assesses new technologies within designated discipline.
  • Verifies and validates test procedures selected and establishes of the test performance characteristics.
  • Provides intra/inter-group scientific leadership and coordination of scientific projects.
  • Collaborates with pathologists and other physicians on the medical necessity of planned assay development.
  • Serves as a consultant to management in long range corporate planning.
  • Maintains availability to provide consultation to the laboratory's clients.
  • Contributes to scientific research, literature to include grant writing, preparation of manuscripts for technical journals, and presentations at scientific meetings.
  • Assists in the development of product positioning, brand strategy and messages for new products.
  • Fulfills the function of section director/technical supervisor for regulatory requirements.
 
QUALIFICATIONS:
  • Must be qualified as a clinical consultant under CLIA regulations Sec. 493.1455. (minimum qualification level at Ph.D. or M.D.) with 4 years of experience. Must have a minimum of 4 years of training or experience, or both, in the appropriate discipline. Must be qualified to manage and direct the laboratory personnel and performance of laboratory testing in accordance with all accrediting bodies, such as CLIA, CAP, MD DOH, NY DOH, AABB as it applies to clinical testing of oversight.  
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write speeches and articles for publication that conform to prescribed style and format.  
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to use Microsoft office products, and various other computer software  products including the Laboratory Information System.
  • Must be certified by the appropriate board of the appropriate discipline: Chemistry