Director of IVD Clinical Operations, Santa Ana

Director of IVD Clinical Operations

5 Days Old

Autonomous Medical Devices Incorporated (AMDI), based in California, is a fast-growing company on a mission to transform point-of-care diagnostics. Our team of world-class engineers, scientists, clinicians, and manufacturing experts is pioneering breakthrough technologies in microfluidics, protein engineering, and cloud-connected data systems. We're gearing up to launch our inaugural products from our ISO 13485-certified, 110,000-square-foot facility in Santa Ana, CA.

Are you ready to help lead the future of medical diagnostic? At AMDI, we're seeking a dynamic Director of IVD Clinical Operations to lead the planning, execution, and management of clinical studies supporting development, regulatory approval, and commercialization of our IVD products. This hands-on role oversees both external clinical trials and our internal Biocollections program, ensuring compliance with FDA, IVDR, MDSAP, GCP, and company standards. You'll work closely with teams across R&D, Assay Development, Engineering, Regulatory, Quality, and Marketing. The ideal candidate will combine demonstrated leadership in the performance of IVD clinical studies for product registration with hands-on operational management skills, ensuring robust clinical evidence generation and regulatory compliance in global markets.

If you're passionate about leading clinical innovation and advancing the future of medical diagnostics, we want to hear from you!

Why Work With Us?

13 company-paid holidays
Competitive vacation and sick days
Daily onsite free lunch, snacks, and drinks
Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance
Monthly socials and employee events
401(k) matching
Education assistance
Casual dress code
Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.

Location: This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred.

Essential Duties and Responsibilities

Lead and manage all Clinical Operations activities, including clinical study design, site selection, initiation, monitoring, and study close-out in compliance with applicable regulations (e.g., FDA 21 CFR Part 812, ISO 14155, IVDR, MDSAP).
Develop and implement clinical strategies that align with product development and regulatory goals.
Hands-on creation of clinical study protocols (CSPs), informed consent forms, case report forms (CRFs), and clinical study reports (CSRs).
Partners with Principal Investigators and their colleagues to develop and execute recruitment plans to meet patient accrual targets for each clinical study.
Provides feedback to AMDI leadership on study progress and is alert to critical details that ensure the study is progressing as planned.
Possesses excellent observational and analytical skills to collect and interpret clinical execution data real time, noting important patterns or outcomes that should be addressed with corrective action.
Design and verification of electronic databases for clinical studies.
Management of the IRB-approved internal Biocollections program.
Serve as a key liaison with regulatory bodies regarding clinical study requirements and submissions.
Familiar with the contracting process for clinical study sites and external service providers.
Responsible for managing storage, packing, and transporting clinical supplies and samples via company-approved couriers.
Participate in risk management, and post-market clinical follow-up (PMCF) activities.
Recruit, develop, and manage the Clinical Operations team as the company grows.

Qualifications Required for Position

Minimum of a Bachelor's degree in life sciences, medicine, clinical research, or a related field.
Minimum of 10 years of experience in clinical studies and clinical operations in the IVD medical device industry.
Minimum of 3 years of experience in a management position or leading a team.
Demonstrated experience in planning and hands-on execution of clinical studies for diagnostic products.
Possess basic knowledge in biochemistry and chemistry and strong understanding of statistics relevant to clinical outcomes assessment.
Proven experience managing clinical teams and external service providers.
In-depth knowledge of IVD regulatory requirements in the US, EU and the MDSAP Participating Countries (e.g., FDA, IVDR, CLIA, MDSAP).
Strong leadership, strategic thinking, and project management skills.
Excellent written and verbal communication skills.
Ability to work in a fast-paced environment and prioritize multiple projects.
Experience with molecular diagnostics, particularly point-of-care devices in CLIA waived settings preferred.
Prior involvement in FDA 510(k) and IVDR submissions preferred.
Familiarity with data management systems (EDC), biostatistics, and clinical data analysis preferred.

Work Environment

This position will require travel (up to 20-30% of the time).
Work requires the individual to be indoors working at a computer station for long periods, in addition to occasional work in a laboratory environment.
Frequently required to wear personal protective gear to prevent exposure to hazardous materials typically found in the lab environment.

Salary Range
The estimated base salary range for this position is $100,000 - $200,000 annually. If the level of the role changes during the hiring process, the applicable base pay range may be updated accordingly. The actual base salary offered will be determined by several factors, including, but not limited to, the applicant's qualifications for the position, years of relevant experience, distinctive skills, and level of education attained.

Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI's internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts.

Our commitment to an inclusive workplace:
We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.

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Location:: Santa Ana

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