Exact Sciences Corporation

Associate Clinical Development Scientist, Clinical Affairs

Job Locations US-Remote
Req No.
2021-9093
Category
Clinical Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Associate Clinical Development Scientist, Clinical Affairs will contribute to the development of clinical evidence plans, clinical development strategies, and study designs to support clinical validation and clinical utility of IVD products. This position works with clinical development leaders and cross-functional study teams to design and execute clinical studies; including, but not limited to, protocol development, data interpretation, clinical study report writing, and scientific communication, such as abstracts, publications, presentations, etc.

 

This position is remote.

Essential Duties and Responsibilities

  • Provide input on clinical development plans and 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 clinical study reports and contribute to abstracts and manuscripts.
  • Provide support in preparation for regulatory submissions, labelling documents, and scientific meetings, such as advisory boards, consultant meetings, and investigator meetings.
  • Coordinate the review of clinical trial data by gathering, analyzing, reviewing, and interpreting data.
  • Support assessment of issues related 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, such as clinical operations, medical affairs, regulatory affairs, research and development, and commercial/marketing, as needed.
  • Excellent scientific writing skills.
  • Apply strong interpersonal and communication skills, both written and verbal.
  • 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 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 lift up to 40 pounds for approximately 5% of a typical working day.
  • Ability to travel 30% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Ph.D., PharmD, or M.D. in a Life Science or Health Science related field; or Bachelor’s Degree and 6 years of relevant experience as outlined in the essential duties in lieu of Ph.D., PharmD, or M.D.
  • 5+ years of experience in a medical device/IVD, biotech, pharmaceutical, or healthcare industry incorporating clinical development or clinical research, research in oncology, molecular biology, or biochemistry.
  • Demonstrated strong understanding of the medical device development process and testing standards for IVDs.
  • Basic understanding of biostatistical principles for study design and data analysis.
  • Strong proficiency in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Access, OneNote, Publisher, or SharePoint.
  • Demonstrated ability to perform the essential duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.

Preferred Qualifications

  • Demonstrated understanding of the FDA submission process to include 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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