Clinical Development Scientist

Exact Sciences • Madison, WI

3d • Remote

About The Position

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Development Scientist will assist the Clinical Development team in developing clinical evidence plans and study designs for clinical validation and clinical utility of LDT and in vitro-diagnostics (IVD) products. This position works with the clinical development team 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.

Requirements

• 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.
• 3 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 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.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Nice To Haves

• Understanding of the FDA submission process to include IDE, PMA, and 510(k).
• Understanding of the medical device development process and testing standards for LDTs and IVDs.

Responsibilities

• Assist with the development of clinical evidence plans for studies related to LDT and IVD medical diagnostic products.
• Assist with preparation of clinical study concepts and protocols.
• Assists with data interpretation, clinical study report writing, and scientific communications, such as abstracts and manuscripts.
• Assist with project management in a matrix management environment.
• Assists with preparation of Clinical Development best practice and SOP documents.
• Conduct and prepare literature reviews, as needed.
• Assist with communication of relevant scientific, clinical, or other findings to both internal and external stakeholders.
• Supports collaborations 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.

Benefits

• 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 .
• We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level