Exact Sciences · 9 hours ago
Clinical Development Scientist
Madison, WI
Full-time
Onsite
Mid Level
$91K/yr - $155K/yr
3+ years expExact Sciences is committed to changing how the world prevents, detects, and guides treatment for cancer. The Clinical Development Scientist will assist in developing clinical evidence plans and study designs for clinical validation and utility of LDT and IVD products, working closely with the clinical development team throughout the study process.
BiotechnologyHealth DiagnosticsManufacturingMedical
No H1B
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
Qualification
Required
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
Preferred
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
Benefits
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Exact Sciences
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M
Leadership Team
Kevin Conroy
Chairman & CEO
Aaron Bloomer
Executive Vice President, CFO
Recent News
2026-02-03
Company data provided by crunchbase