Director Ivd Product Development Jobs (NOW HIRING)

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visitguardanthealth.comand follow the company onLinkedIn,X (Twitter)andFacebook.

Department Summary

The Technology Development Department is responsible for developing, validating, and implementing the tests used by Guardant Health for cancer detection. This role will be within the Product Development wing of Technology Development. The Product Development group is primarily responsible for late-stage assay development, including interfacing with early-stage assay development to finalize the assay, verifying and validating the product, and supporting transfer of the product to the Guardant health clinical laboratory and subsequent launch. The current focus of the role will be supporting regulatory submissions to both FDA and ex-US regulatory agencies as subject matter experts in clinical validation studies. However, the full scope additionally includes LDT and RUO product development and analytical validation utilizing standard design control processes.

About the Role

The Clinical Development Scientist will support the design, execution, and interpretation of clinical studies for oncology-focused in vitro diagnostic products. The scientist will be responsible for developing clinical evidence strategies and managing clinical validation studies suitable for regulatory submissions, for both internal projects and with external partners. The scientist will work cross-functionally with clinical, regulatory, biostatistics, medical affairs, R&D, and quality teams. The scientist will also have opportunities to assist in the product development, analytical validation, and transfer of assay to the clinical laboratory and post-launch support of the products.

Essential Duties and Responsibilities

• Develop and execute clinical development strategies for oncology IVD products, including clinical validation studies intended to support regulatory submissions.
• Design clinical study protocols, statistical analysis plans, sample plans, and clinical evidence packages in collaboration with biostatistics, regulatory, medical, and product development teams.
• Manage clinical validation studies from concept through completion, including study design, site/vendor coordination, data review, issue resolution, and final report generation.
• Ensure clinical studies are scientifically rigorous, operationally feasible, and aligned with regulatory expectations and product claims.
• Partner with regulatory affairs to support submission strategy and preparation of clinical sections for regulatory filings.
• Work closely with R&D, assay development, bioinformatics, quality, and operations teams to ensure clinical study requirements are incorporated into product development plans.
• Analyze and interpret clinical study data, summarize findings, and communicate results to internal and external stakeholders.
• Contribute to risk assessments, evidence planning, intended-use refinement, claims development, and product launch readiness.
• Support interactions with external collaborators, clinical sites, vendors, key opinion leaders, and regulatory agencies as needed.
• Maintain awareness of evolving regulatory expectations, clinical practice guidelines, and competitive trends in oncology diagnostics.

Essential Qualifications:

• Advanced degree in a relevant scientific, medical, or clinical discipline, such as molecular biology, genetics, oncology, pathology, clinical laboratory science, or a related field. PhD, PharmD, MD, or equivalent preferred; Master's degree with significant relevant experience may be considered.
• At least 5 years post-graduate industry experience (assuming PhD)
• Experience designing, managing, and interpreting clinical validation studies for IVD products, particularly studies intended to support regulatory submissions.
• Experience with IVD product development in oncology, including familiarity with clinical performance evaluation, intended use development, and diagnostic claims.
• Strong understanding of clinical study design, clinical validation principles, clinical evidence generation, and regulatory-grade documentation.
• Ability to work effectively in cross-functional teams involving clinical development, regulatory affairs, biostatistics, R&D, quality, medical affairs, and product management.
• Excellent scientific writing and communication skills, including experience drafting protocols, reports, summaries, and submission-supporting documents.
• Strong organizational skills and ability to manage multiple projects, timelines, and stakeholders.

Preferred Qualifications:

• Experience with NGS-based IVD device development, including molecular profiling, companion diagnostics, tumor genomics, liquid biopsy, or tissue-based oncology testing.
• Regulatory experience with FDA, IVDR, PMA, De Novo, 510(k), or other global IVD submission pathways.
• Experience supporting clinical validation studies for companion diagnostics or oncology biomarker assays.
• Familiarity with GCP, GLP, CLIA, CAP, ISO 13485, design control, and relevant IVD regulatory standards.
• Experience working with clinical trial samples, retrospective sample sets, biobanks, external clinical sites, or CROs.
• Knowledge of oncology treatment paradigms, biomarker-driven therapy selection, and clinical guideline development.
• Familiarity with AI tools

AI & Digital Fluency

• Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.