Position Summary
Our Client, a large comprehensive reference lab in south eastern, PA, is seeking a Scientific Director to oversee several clinical departments, including clinical chemistry, immunology, urinalysis, and hematology. A strong emphasis on quality management and strategic thinking in area of expertise is important. This role acts as the on-site technical/clinical resource for our laboratory team and clients in these laboratory disciplines areas. This is an exciting clinical leadership opportunity for the right candidate to work with our excellent operational team to support and direct our clinical chemistry (and beyond) program.
This position reports directly to the Chief Laboratory Operations and Integration Officer.
Job Responsibilities
Designs, implements and directs development of assays critical to corporate strategies and client requirements. Responsible for the selection of test methodology that is appropriate for the clinical use of the test results. Investigates and assesses new technologies within designated discipline.
Responsible for the verification and validation of test procedures selected and establishment of the test performance characteristics.
Responsible for quality of all test results emanating from areas of responsibility.
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.
Evaluates and documents approval of all validations and methods used by the laboratory area and proposes new or modified analytical procedures. Performs a review of the laboratory technical procedures and documents such review was conducted. Modifies and validates procedural changes as appropriate.
Reviews and approves the training, quality assurance, and proficiency testing programs.
Contributes to scientific research, including grant writing, preparation of manuscripts for technical journals, and presentations at scientific meetings.
Assists in the development of product positioning, brand strategy and messaging.
Maintains library of relevant materials for employees. Teaches laboratory staff through lectures, journal club presentations and one on one and group education sessions.
Fulfills the function of section director/technical supervisor for regulatory requirements
Job Qualifications
Doctoral in Life Sciences discipline
Board Certification from the American Board of Clinical Chemistry or equivalent clinical board program
5-7 years of experience in a busy clinical laboratory setting preferred
Excellent written and spoken communication skills
Successful Leadership expertise
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 genetics, 2 of which have been in Clinical Cytogenetics.
Essential Responsibilities
Designs, implements and directs development of assays critical to corporate strategies and client requirements.
Responsible for the selection of test methodology that is appropriate for the clinical use of the test results.
Investigates and assesses new technologies within designated discipline.
Responsible for the verification and validation of test procedures selected and establishment 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.
Be available 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