Diagnostics Clinical Lead

About the role

We are seeking a proactive, strategic, and experienced leader to spearhead Cleancard’s clinical research! You will own the clinical pillar of the business, including IRB applications, clinical study design, management, and analysis, as well as grant funding and clinical QMS. You will define a clinical roadmap that sets up Cleancard for short and long term success. You will manage relationships with clinical partners and regulatory consultants, bringing them together with our cross-disciplinary team of scientists and engineers to deliver on the clinical studies that demonstrate the potential of our non-invasive cancer diagnostic. You will be an integral member of our tight knit team and involved in the overall development of our product and company! We will build a team around you to make sure that our technology makes it to market and can help as many patients as possible! Your ownership of our clinical and patient relationships will also be the starting point for our future sales network. This role is based in our San Francisco HQ.

Even if you feel like you don’t meet all of the qualifications, we encourage you to apply!

Research shows that while men apply to jobs where they meet an average of 60% of the criteria, women and other underrepresented people tend to only apply when they meet 100% of the qualifications. At Cleancard, we welcome diverse perspectives and people who think rigorously and aren’t afraid to challenge the status quo. Cleancard is an equal opportunity employer; we celebrate diversity and are committed to creating an inclusive environment, free from discrimination or harassment, for all employees.

Key Responsibilities

• Manage clinical studies, to include overall design with cohort and sample selection, as well as communication with sites.
• Perform robust data analysis on clinical data and manage the experimental plan.
• Plan, manage, and analyze clinical studies intended for US FDA submissions.
• Manage IRB applications and study design documentation.
• Identify and execute grant funding opportunities.

Requirements:

• BS in STEM (Grad-level degree in a relevant field e.g. MD or MS/PhD within clinical research is preferred)
• Demonstrated experience in clinical study design from initial concept to execution for in vitro diagnostics and/or medical devices.
• Strong knowledge of FDA (CDRH) requirements and pathways for clinical diagnostics
• Experience with using clinical QMS systems, eTMF, and/or EDC for a clinical diagnostic is highly desirable.
• Certificate in clinical trial management, clinical research administration, etc. preferred (ACRP, SOCRA, etc.)
• Strategic clinical trial design
• Experience with designing pivotal and multi-site clinical studies and clinical trials (not just pilot studies)
• Experience with supporting clinical materials for regulatory submissions (FDA)
• Compliance to Good Clinical Practice, 21 CFR 11, 21 CFR 50, 21 CFR 54, 21 CFR 814, ICH E6(R3), ISO 141550
• Proactive and able to independently manage tasks to meet deadlines.
• Excellent attention to detail and strong written and verbal communication skills.
• Ability to successfully participate in a fast-paced, highly creative and enthusiastic, start-up environment with people who are motivated to succeed together as a team.

Optional but preferred:

• Experience with oncology diagnosis and recurrence
• Previous startup experience
• Experience with managing CROs
• Experience with IDE applications, 21 CFR 812
• Grant writing for clinical trials (SBIR, etc.)
• Experience with supporting clinical materials for non-US regulatory submissions (EU IVDR, EU MDR, Health Canada, Japan, China, etc.)
• Well networked with US hospital systems, etc.
• Biostatistics skills

Why Join Us:

• Be part of a visionary team working on important research in non-invasive cancer diagnostics.
• Work in a collaborative and innovative environment with leading experts across various fields.
• Competitive salary and benefits package.
• Opportunities for professional growth and development in a fast-paced startup setting.
• Make a tangible impact on healthcare and improve patient outcomes through at-home diagnostics.