Clinical Research, Clinical Safety Manager

Job Overview

Castle Biosciences Inc. is growing, and we are looking to hire a full‑time Clinical Research, Clinical Safety Manager who will work from our Phoenix, AZ, Friendswood, TX or Pittsburgh, PA office locations, with a start date of August 1, 2026.

• Excellent Annual Salary + 20% Bonus Potential
• 20 Accrued PTO Days Annually + 10 Paid Holidays
• 401K with 100% Company Match up to 6%
• 3 Health Care Plan Options + Company HSA Contribution
• Company Stock Grant Upon Hire

The Clinical Research Safety Manager is responsible for establishing, implementing, and continuously improving clinical research safety processes for a laboratory‑developed test (LDT) and medical device organization while ensuring compliance with applicable regulations, Company policies, and Standard Operating Procedures (SOPs). This role serves as the operational safety lead for company‑sponsored clinical studies, overseeing safety planning, adverse event management, risk assessments, safety reporting, and regulatory documentation for FDA‑regulated LDT, IVD, and medical device studies.

The position partners with cross‑functional teams to ensure participant safety, regulatory compliance, inspection readiness, and alignment between clinical safety activities, quality systems, and post‑market processes. This individual contributor role also supports the development of safety processes, study documentation, and training while providing support as directed by leadership and contributing to the growth of the clinical research safety function.

• Bachelor's degree in life sciences, nursing, clinical research, biomedical sciences, regulatory/quality, public health, or related field.
• 5+ years of clinical research, clinical safety, medical device/IVD, diagnostics, regulatory, quality, or related experience in a regulated healthcare environment.
• Demonstrated experience supporting sponsor‑led clinical studies, preferably device/IVD/LDT studies, including protocol review, safety reporting pathways, IRB/EC interactions, and study documentation.
• Working knowledge of FDA clinical research and medical device requirements, including 21 CFR Parts 803, 812, and 820 and applicable safety/reporting expectations.
• Experience evaluating and documenting adverse events, serious adverse events, unanticipated problems, unanticipated adverse device effects, protocol‑defined events, deviations, and safety issues.

• Monday‑Friday, 40 hours per week, working from Phoenix, AZ, Friendswood, TX or Pittsburgh, PA office locations.
• Occasional overnight travel, up to 10%, may be required to support site engagement, audits/inspections, study meetings, training, or conferences.

All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H‑1B visas, OPT, or employment‑related visas.

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e‑mail Reasonable Accommodations
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** No third‑party recruiters, please.