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Position Overview

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

Essential Duties

Include, but are not limited to, the following:

• Supports development of clinical evidence plans for studies related to LDT and IVD medical diagnostic products.
• Supports preparation of clinical study concepts and protocols.
• Supports data interpretation, clinical study report writing, and scientific communications, such as abstracts and manuscripts.
• Project management in a matrix management environment.
• Supports development of Clinical Development best practice and SOP documents.
• Supports collaborations with key opinion leaders (KOLs), biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
• Provide support in preparation for regulatory submissions, labelling documents, and scientific meetings, such as advisory boards, consultant meetings, and investigator meetings.
• 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.
• 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 and interpersonal communication 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.

Minimum Qualifications

• Ph.D. or Master's Degree in a Life Science or Health Science related field or field as outlined in the essential duties; or Bachelor's Degree in a Life Science or Health Science related field or field as outlined in the essential duties and 5 additional years of relevant experience in lieu of a Ph.D. or Master's Degree.
• 5 years of relevant 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 understanding of the medical device development process and testing standards for LDTs and IVDs.
• Demonstrated scientific writing, interpersonal communication, and critical thinking skills.
• 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).

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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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. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.