Senior Principal Scientific Affairs Advisor – General Medicine, Medical Imaging

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer scientific and medical guidance for the gastroenterology therapeutic area to both internal and external stakeholders.

• Work alongside Business Development to secure new business prospects and enhance market presence.

• Act as a scientific consultant to sponsors regarding imaging strategies and their application in clinical trials.

• Assist study teams and internal departments by providing expert advice on trial design, image review techniques, and quality control standards.

• Discover and implement innovative tools, technologies, and process enhancements to improve operational efficiency.

• Collaborate with cross-functional teams to ensure that technology upgrades and service offerings are aligned with organizational goals.

• Guarantee scientific accuracy, quality, compliance, and integrity across all project outputs.

• Aid in the development and review of imaging charters, imaging manuals, review protocols, study reports, and other technical documentation.

• Collect and document scientific and business requirements from clients and internal stakeholders.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Medical Imaging, Medicine, Clinical Research, or a related scientific field.

• At least 10 years of clinical trial experience in a CRO, pharmaceutical, biotechnology, or similar research organization.

• Significant experience in supporting imaging-focused clinical trials.

• Experience in regulated environments, including: GCP, GLP, ICH Guidelines, FDA Regulations, ISO Standards, and 21 CFR Part 11.

• Proficient in project planning, reporting, financial oversight, and resource management.

• Proven experience in scientific research with an established record of publications.

• Experience in collaborating with cross-functional stakeholders and external sponsors.

• Advanced understanding of clinical research methodologies and medical imaging applications.

• Strong grasp of project management and data management principles.

• Proficient in Microsoft Office applications, particularly Word and Excel.

🏝️ Benefits

• Opportunities for professional development.

• Participation in global team events.