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Clinical Development Scientist

1 month ago

Madison, Wisconsin, United States Exact Sciences Full time
Job Description

Transforming Cancer Prevention and Detection

At Exact Sciences, we're pioneering a new era in cancer prevention and detection. Our innovative approach empowers patients and clinicians to make informed decisions when it matters most. As a Senior Clinical Development Scientist, you'll play a pivotal role in shaping our clinical evidence plans, developing clinical development strategies, and designing study protocols for our life-changing diagnostic products.

Key Responsibilities

  • Contribute to the development of clinical evidence plans for studies related to LDT and IVD medical diagnostic products.
  • Design clinical study concepts and prepare study protocols, collaborating with cross-functional teams and Clinical Development leadership.
  • Prepare clinical study reports and support data interpretation and scientific communications, such as abstracts, publications, and presentations.
  • Project manage in a matrix management environment, ensuring seamless collaboration with stakeholders.
  • Develop Clinical Development best practice and SOP documents, driving excellence in our processes.
  • Collaborate with key opinion leaders, biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
  • Support preparation for scientific meetings, regulatory submissions, and labeling documents, ensuring accuracy and compliance.
  • Coordinate review of clinical trial data, including gathering, analyzing, reviewing, and interpreting data, and providing preliminary assessments and recommendations.
  • Assess issues related to protocol conduct and subject safety, ensuring the highest standards of clinical research.
  • Participate in scientific meetings, advisory boards, and investigator meetings, representing Exact Sciences with expertise and professionalism.
  • Conduct and prepare literature reviews, as needed, to inform clinical development strategies.
  • Evaluate research proposals for scientific, medical, business, scientific, and operational feasibility, ensuring alignment with our goals.
  • Contribute to the authoring and revision of regulatory submissions, ensuring compliance with regulatory requirements.
  • Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders, promoting transparency and collaboration.
  • Collaborate with other functions, including clinical operations, medical affairs, regulatory affairs, research and development (R&D), and commercial/marketing, as needed, to drive business success.
  • Develop and maintain excellent scientific writing skills and interpersonal communication skills, ensuring effective collaboration and stakeholder engagement.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, demonstrating a commitment to excellence.
  • Support and comply with the company's Quality Management System policies and procedures, ensuring adherence to regulatory requirements.
  • Maintain regular and reliable attendance, ensuring continuity of our clinical development efforts.
  • Act with an inclusion mindset and model these behaviors for the organization, promoting a culture of respect and belonging.
  • Work designated schedule, ensuring flexibility and adaptability in a dynamic environment.
  • 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, ensuring productivity and efficiency.
  • Work seated for approximately 25% of a typical working day and standing for approximately 75% of a typical working day, ensuring a healthy work-life balance.
  • Lift up to 40 pounds for approximately 5% of a typical working day, ensuring physical safety and well-being.
  • Comply with any applicable personal protective equipment requirements, ensuring a safe working environment.
  • Travel 30% of working time away from work location, including overnight/weekend travel, ensuring flexibility and adaptability in a dynamic environment.

Requirements

  • 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.