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Senior Clinical Research Scientist
2 months ago
Position Overview
The Senior Clinical Research Scientist will play a pivotal role in the formulation of clinical evidence strategies, clinical development frameworks, and study methodologies aimed at validating and demonstrating the clinical efficacy of laboratory-developed tests (LDT) and in vitro diagnostic (IVD) products. This role collaborates closely with clinical development leaders and interdisciplinary study teams to orchestrate clinical trials from initial concept through protocol formulation, data analysis, clinical study report generation, and scientific dissemination (e.g., abstracts, publications, presentations).
Key Responsibilities
- Facilitates the creation of clinical evidence strategies for studies associated with LDT and IVD medical diagnostic products.
- Assists in the drafting of clinical study concepts and protocols.
- Contributes to data analysis, clinical study report generation, and scientific communications, including abstracts and manuscripts.
- Manages projects within a matrix organizational structure.
- Supports the development of best practices and standard operating procedures (SOPs) in Clinical Development.
- Engages with key opinion leaders (KOLs), biostatisticians, and external consultants to integrate clinical science insights into clinical evidence strategies.
- Provides assistance in the preparation of regulatory submissions, labeling documents, and scientific gatherings, such as advisory boards and investigator meetings.
- Monitors and evaluates issues related to protocol execution and participant safety.
- Participates in scientific conferences, advisory boards, and investigator meetings.
- Conducts and compiles literature reviews as necessary.
- Contributes to the drafting and revision of regulatory submissions.
- Facilitates the communication of relevant scientific, clinical, or other findings to both internal and external stakeholders.
- Collaborates with various functions, including clinical operations, medical affairs, regulatory affairs, research and development, and commercial/marketing, as required.
- Exhibits excellent scientific writing and interpersonal communication abilities.
- Demonstrates strong interpersonal and communication skills, both written and verbal.
- Embodies the company’s mission and values through accountability, innovation, integrity, quality, and teamwork.
- Adheres to the company’s Quality Management System policies and procedures.
- Maintains consistent and reliable attendance.
- Demonstrates an inclusive mindset and models these behaviors within the organization.
- Possesses the 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.
- Capable of working on a computer and phone simultaneously.
- Ability to utilize a telephone through a headset.
- Ability to lift up to 40 pounds for approximately 5% of a typical working day.
- Willingness to travel 30% of working time away from the primary work location, which may include overnight and weekend travel.
Minimum Qualifications
- Ph.D. or Master’s Degree in a Life Science or Health Science related field; or a Bachelor’s Degree in a Life Science or Health Science related field with 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 focusing on clinical development or clinical research, particularly in oncology, molecular biology, or biochemistry.
- Proven understanding of the medical device development process and testing standards for LDTs and IVDs.
- Demonstrated scientific writing, interpersonal communication, and critical thinking capabilities.
- Basic knowledge of biostatistical principles for study design and data analysis.
- Strong proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, Access, OneNote, Publisher, or SharePoint.
- Demonstrated ability to fulfill 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, including IDE, PMA, and 510(k).
Salary Range:
$109,000.00 - $174,000.00. The annual base salary is for this position and may vary based on hiring location. This position is also bonus eligible and may receive company stock upon hire and annually.
Exact Sciences is committed to providing an employee experience that includes paid time off (vacation, holidays, volunteering, and personal time), paid parental and caregiver leave, a retirement savings plan, wellness support, and comprehensive health benefits including medical, prescription drug, dental, and vision coverage.
