Clinical Development Scientist

    • Madison, WI

Summary of Major Responsibilities

The Clinical Development Scientist facilitates and contributes to the development and implementation of new clinical testing within the laboratory. This role serves as a scientific resource and provides up-to-date evidence relevant to test development and implementation. Knowledge of laboratory information management systems, infectious disease, genomics and molecular diagnostics is critical to the success of the Clinical Development Scientist. This role will support internal and external collaborations in partnership with the Medical Director, Clinical Laboratory Directors, Technical Transfer and clinical laboratory teams.

Essential Duties and Responsibilities

  • Develop, lead, and mentor a team of associates.
  • Mentor and/or train new clinical scientists.
  • Read and synthesize major scientific data sources (clinical trials, studies, published reports, etc.) and communicate key findings to collaborators.
  • Oversee and manage the activities involved in the development, optimization and implementation of new test methods and test systems.
  • Guide development of transfer protocols and reports.
  • Lead and assist in the development and maintenance of QC programs.
  • Attend regional and national scientific and clinical meetings.
  • Work collaboratively with the Medical Director and Clinical Laboratory Directors on the clinical development plan.
  • Contribute to development of long-range strategic clinical laboratory planning.
  • Partner with data management teams and contribute to the development of a data quality plan.
  • Recruit, develop, and retain a diverse and highly capable clinical scientist team.
  • Manage complex, cross-functional projects with a good knowledge of clinical laboratory regulations and guidelines.
  • Identify and share best practices with oversight for the implementation of best practices for business processes.
  • Ability to clearly communicate complex scientific ideas to a broad audience in order to promote and implement an expanding testing menu at Exact Sciences laboratories.
  • Strong problem-solving skills with the ability to anticipate problems, diagnose root causes, and take corrective action to prevent reoccurrence.
  • Ability to embrace diversity of thought to model innovative behaviors (reach across boundaries, empower others, and lead decisively in the face of ambiguity).
  • Self-directed with a strong work ethic coupled with ability to work in a goal-oriented environment.
  • Demonstrated strong organizational and technical writing skills.
  • Excellent interpersonal, verbal communication, and influence skills.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to lift up to 40 pounds for approximately 5% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to work on a computer and phone simultaneously.
  • Ability to use a telephone through a headset.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel between Madison locations.
  • Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • PhD and/or MD in clinical laboratory or life science field.
  • 5+ years of experience mentoring and developing staff.
  • 4+ years of professional experience in the clinical laboratory or biotechnology industry.
  • 1+ year of experience leading a team with 1 or more direct report(s).
  • Strong knowledge of CAP, CLIA, AND HIPAA rules and regulations.
  • Strong computer skills to include Internet navigation, Email usage, word processing, advanced Excel functions and building presentations for all audiences.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • Strong knowledge of human subject regulations and clinical trials.
  • Board Certification for Laboratory Directors of High Complexity Testing (ABB, ABCC, ABFT, ABHI, ABMGG, ABMLI, ABMM, or NRCC).
  • Experience working in a CLIA laboratory.

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EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.


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