Associate Scientific Director (Molecular Infectious Diseases)

Quest Diagnostics•Lewisville, TX

About The Position

The Associate Scientific Director directs, plans, and manages the scientific and medical quality of the technical department in Infectious Diseases, or in Molecular Biology or Microbiology. The role works with scientists and medical laboratory scientists to develop and optimize clinical assays, and advises management and technical personnel on development technologies and activities. The position is accountable for the quality and timeliness of projects and is responsible for advancing scientific knowledge in Infectious Diseases. The role oversees assay research and development, feasibility studies, new product development, assay and platform improvements, troubleshooting, and product launches. It monitors quality control and proficiency testing, supports compliance with CLIA, CAP, and state requirements, and provides clinical consultation to laboratory clients. The Associate Scientific Director participates in scientific, business, and policy decisions; provides education and training; represents Quest Diagnostics in the scientific community; and may serve as principal investigator on industry-sponsored 510(k)/PMA submissions for investigative devices and assays. Most work is performed at a desk, with some work in an office or laboratory. Laboratory activities may involve equipment operation, manual dexterity, visual acuity, and safe handling of chemicals. The position requires occasional lifting and moving of objects up to 25 pounds.

Requirements

Ph.D. in Molecular Biology, Microbiology, or equivalent; a doctorate in a scientific field or equivalent combination of education and experience is required.
Typically at least 2 years of work experience, inclusive of postdoctoral fellowship.
Experience managing technical professionals, with demonstrated supervisory and leadership abilities.
Ability to lead projects and programs, set standards, train staff, and develop staff to solve technical problems independently.
Understanding of diagnostic product development processes and design controls under FDA Quality System Regulations for medical devices.
Ability to resolve conflicts at project-team and management levels.
Excellent command of English language and grammar, with strong written and oral communication skills.
Ability to understand and critically analyze product development documents, business presentations, technical journals, and governmental regulations.
Ability to write clear, concise reports and business correspondence and effectively present information to varied audiences.
Ability to calculate basic statistical measures for quality control and work with probability, statistical inference, linear algebra, and curve fitting well enough to guide staff and assess departmental work.
Ability to define problems, collect data, establish facts, draw conclusions, analyze technical and business information, account for data limitations and assumptions, and evaluate conclusions generated by others.

Nice To Haves

Familiarity with clinical laboratory practices and operations.
D(ABMM) certification or eligibility.

Responsibilities

Direct, plan, and manage Infectious Diseases activities for feasibility studies, new product development, assay modifications and improvements, new and modified testing platforms, troubleshooting, and product launches.
Ensure proficiency testing is conducted on time, reviewed by appropriate staff, and followed by approved corrective action when results are unsatisfactory.
Monitor quality control to maintain acceptable analytical performance for each test system and ensure patient results are reported only when the system is functioning properly.
Work with clinical laboratory operations staff to ensure assays perform as expected and laboratory practices meet CLIA, CAP, and state regulatory requirements.
Advise executive leadership and technical personnel on development technologies and activities.
Provide input on research developments and recommend tests consistent with internal business mandates.
Attend Subspecialty Team and senior laboratory management meetings and participate in significant scientific, business, and policy decisions affecting clinical utility and testing quality.
Provide and participate in educational programs for medical and laboratory staff.
Provide clinical consultation to laboratory clients.
Participate in continuous improvement using LeanThinking.
Direct ongoing research and development of new assays and troubleshooting or improvement of current assays.
Represent Quest Diagnostics in the scientific community through services, publications, and presentations.
Teach didactics to pathology residents and medical technologists or students in training.
Participate as principal investigator in industry-sponsored 510(k)/PMA submissions for investigative devices and assays.
Lead projects and programs, set standards, train staff, and develop staff to independently solve technical problems.
Manage technical professionals and demonstrate supervisory and leadership abilities.