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.

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.
• 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

Qualifications

• 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

Skills

• 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.
• 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

Benefits

Competitive salary and benefits package.

Pay

$120K - $220K

Schedule

Full-time