Clinical Development Scientist

Guardant Health • Palo Alto, CA

1d • $138,400 - $190,300 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time.
• Annualized base salary ranges are provided.
• Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs.
• A background screening including criminal history is required for this role.
• Guardant Health is an Equal Opportunity Employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior