Director Clinical Affairs

About Clarix Imaging:

Clarix Imaging is a commercial-stage medical technology company headquartered in Chicago, IL. Founded by world-renowned medical imaging scientists from the University of Chicago, our mission is to empower clinicians with high-clarity tumor visualization and intelligent analysis, enabling precision and personalized medicine through groundbreaking innovations in imaging science and AI. Our products utilize advanced algorithms, innovative system design, and high-performance computing to meet critical clinical needs in surgical oncology, radiology, and pathology. We are seeking passionate individuals with an entrepreneurial spirit to join our dynamic team!

Position Overview:

We are seeking an experienced clinical operations leader who is dedicated to enhancing outcomes in cancer surgery. This role will involve the development and coordination of strategic clinical evidence-generation activities aimed at supporting regulatory clearance for new products and indications, as well as post-market studies. The successful candidate will be responsible for the planning, implementation, execution, and management of clinical studies, overseeing day-to-day operations while collaborating closely with external researchers, clinical sites, their teams, and third-party vendors. You will work across various departments to contribute to integrating the cutting-edge imaging technologies developed at Clarix Imaging into routine clinical applications and workflows.

Responsibilities:

• Lead the development of the company's clinical and scientific strategies for clinical studies for pre-market submission and post-market studies to meet business goals and objectives.
• Provide strategic guidance for global clinical evidence programs.
• Direct the formulation of clinical research strategies, including timelines, milestones, project plans, deliverables, budget management, and resource allocation.
• Develop and manage the clinical research infrastructure, which includes the creation of clinical research protocols, case report forms, informed consent documents, and the management of trial master files. This also involves assisting study sites with the Institutional Review Board (IRB) process and documentation preparation, as well as overseeing study monitoring and investigator requirements, recruitment, and contract preparation.
• Establish clinical research workflows, encompassing data collection, management, analysis, interpretation of clinical data, and the preparation of clinical study reports.
• Supervise and train clinical research staff, including consultants and third-party partners.
• Contribute to the development of clinical research components for grant applications.
• Provide both onsite and remote support for clinical research projects.
• Oversee the timely capture, reporting, and assessment of adverse events.
• Prepare progress reports regarding clinical research activities.
• Foster cross-functional collaboration with key organizational functions to influence the external environment through engagement with notified bodies, regulatory agencies, and external working groups.
• Ensure compliance with corporate standard operating procedures (SOPs) and regulatory requirements.
• Author peer-reviewed journal publications, conference abstracts, proceeding papers, educational white papers, case studies, and other clinical educational materials.

Required Qualifications:

• A strong academic background, including a master’s degree in a relevant field, is required; a PhD or Medical Degree is preferred.
• A minimum of five years of professional experience in medical or clinical affairs within the medical device industry is required.
• Prior experience in medical imaging is highly preferred.
• Comprehensive knowledge of Good Clinical Practice (GCP), 21 CFR medical device regulations, ISO 14155, and Medical Device Regulation (MDR) as well as other international regulations is essential.
• In-depth knowledge of breast cancer and surgical oncology is required; experience in operating room settings is preferred.
• An entrepreneurial mindset with strong collaborative abilities, strategic thinking, and excellent project management skills, along with the capacity to prioritize and plan effectively.
• Exceptional verbal and written communication skills, along with strong presentation abilities, team-building experience, and interpersonal skills to engage effectively with diverse stakeholders.
• Candidates should be based in the Greater Chicago or Los Angeles areas, with the willingness to travel up to 40% to clinical sites nationwide.