Exact Sciences Corporation

Clinical Development Scientist, Clinical Affairs

Job Locations US-Remote
Req No.
2021-9091
Category
Clinical Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Clinical Development Scientist, Clinical Affairs is responsible for the development of clinical evidence plans, clinical development strategies, and study designs to support clinical validation and clinical utility of in vitro-diagnostics (IVD) products.  This position works with cross-functional study teams to design and execute clinical studies, including protocol development, data interpretation, clinical study report writing, and scientific communication (e.g., abstracts, publications, presentations).

Essential Duties and Responsibilities

  • Develop clinical strategy, create clinical development plans, write clinical protocols, and report results.
  • Collaborate with key opinion leaders (KOLs), biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
  • Write abstracts, manuscripts, and clinical study reports.
  • Provide support in preparation for scientific meetings (e.g., advisory boards, consultant meetings, and investigator meetings), regulatory submissions, and labelling documents.
  • Coordinate review of clinical trial data, including gathering, analyzing, reviewing, and interpreting data; provide preliminary assessments and recommendations.
  • Support assessment of issues relating to protocol conduct and subject safety.
  • Participate in scientific meetings, advisory boards, and investigator meetings.
  • Conduct and prepare literature reviews, as needed.
  • Evaluate research proposals for scientific, medical, business, scientific, and operational feasibility.
  • Contribute to the authoring and revision of regulatory submissions.
  • Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders.
  • Collaborate with other functions; including clinical operations, medical affairs, regulatory affairs, research and development (R&D), and commercial/marketing, as needed.
  • Excellent scientific writing skills and interpersonal communication 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.
  • Maintain regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to work designated schedule.
  • 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 seated for approximately 25% of a typical working day. Ability to work standing for approximately 75% of a typical working day.
  • Ability to lift up to 40 pounds for approximately 5% of a typical working day.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability to travel 30% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Ph.D., Pharm.D., or M.D. in Life Science or Health Science field; or Bachelor’s Degree in Life Sciences or field as outlined in essential duties and 8 years of relevant experience in lieu of Ph.D., Pharm.D., or M.D.
  • 6+ years of experience in medical device/IVD, biotech, pharmaceutical, or healthcare industry, incorporating clinical development or clinical research, research in oncology, molecular biology, biochemistry, or field as outlined in essential duties.
  • Demonstrated comprehensive understanding of the medical device development process and testing standards for IVDs.
  • Basic understanding of biostatistical principles for study design and data analysis.
  • 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

  • Professional working knowledge of the FDA submission process; including IDE, PMA, and 510(k).

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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