Senior Clinical Studies Specialist

ARK Diagnostics, Inc.•Fremont, CA

1d•$145,000 - $170,000•Onsite

About The Position

ARK Diagnostics, Inc. is advancing the development of high-performance IVD assays that support precise clinical decision-making. We are looking for a Senior Clinical Affairs Specialist to lead the design and execution of clinical validation studies, ensuring that our products meet the highest scientific and regulatory standards. In this role, you will serve as the primary liaison with academic collaborators, reference laboratories, and clinical partners, guiding the acquisition and use of well-characterized clinical specimens for FDA and IVDR design validation submissions. You will provide clinical expertise across the product lifecycle, from study planning and method comparisons to regulatory documentation, labeling, and Instructions for Use (IFU). This position is ideal for a candidate with extensive IVD clinical experience, strong technical writing skills, and the ability to align clinical strategy with regulatory requirements and commercialization goals. Your contributions will directly support the safe and effective launch of diagnostic assays that impact patient care.

Requirements

Bachelor’s degree in Life Sciences, Medical Technology, or a related scientific field required (advanced degree such as an Master’s or Ph.D. preferred).
7+ years of experience in clinical affairs, regulatory affairs, or clinical research operations required (IVD industry experience with a focus on FDA/IVDR submissions strongly preferred).
Demonstrated experience working with external academic experts, reference laboratories, and clinical partners.
Excellent biomedical and regulatory technical writing skills, including protocol and report review/approvals.
Ability to operate cross-functionally and align clinical strategy with development and commercialization objectives.

Responsibilities

Establish and manage relationships with academic experts and reference laboratories to support clinical validation of IVD products under development.
Identify appropriate clinical sites, reference methods, and specimen sources; secure well-characterized clinical specimens suitable for FDA and/or IVDR design validation submissions.
Provide clinical input into Design Input Requirements, hazard assessments, method comparison protocols, and regulatory-facing study reports to ensure compliance and scientific rigor.
Contribute to clinical and regulatory documentation, including labeling and Instructions for Use (IFU), while collaborating cross-functionally with Program Management, R&D, RA/QA, Marketing, and Customer Support throughout the product lifecycle