Sr Clinical Development Scientist at Exact Sciences

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Position Overview

The Senior Clinical Development Scientist is responsible for 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 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).

This position is remote.

Essential Duties

Include, but are not limited to, the following:

• Contributes to the development of clinical evidence plans for studies related to LDT and IVD medical diagnostic products.
• Designs clinical study concepts and prepares study protocols, partnering with other cross-functions and Clinical Development leadership.
• Prepares clinical study reports and supports data interpretation and scientific communications, such as abstracts, publications, presentations.
• Project management in a matrix management environment.
• Develops Clinical Development best practice and SOP documents.
• Collaborate with key opinion leaders (KOLs), biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
• 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.

Minimum Qualifications

• Ph.D. or M.D.  in Life Science or Health Science field or field as outlined in the essential duties; or Master’s 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 M.D.
• 8 years of relevant 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 LDTs and IVDs.
• Demonstrated scientific writing, interpersonal communication, and critical thinking skills.
• 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).
• Professional working knowledge of IVDR and PMDA submission processes.

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Salary Range:

$129,000.00 - $208,000.00

 

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.

 

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.

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