Principal Scientist, Clinical Biomarkers
$140,000–$187,000 year
On-site · San Francisco, California, United States
Job Summary
Principal Scientist, Clinical Biomarkers: develops and implements comprehensive biomarker strategy for one or more clinical studies, drives generation and interpretation of biomarker data to inform program development, and authors biomarker sections for study protocols, SAPs, and regulatory documents (CSR, IB, BLA). Collaborates with internal SMEs and external CROs for vendor selection, qualification, and technology transfer of biomarker assays; oversees multiple outsourced projects and collaborates with cross-functional teams to execute translational studies and analyze biomarker datasets. Stays current with emerging biomarker technologies and trends in transplant and immune-mediated diseases; contributes to decision-making through scientific communication, data-driven recommendations, and stakeholder engagement in a highly matrixed environment.
Required Qualifications
- PhD and/or postdoctoral training in immunology, molecular or cellular biology, translational sciences, or a related discipline
- 5+ years of relevant industry experience with direct involvement in developing and implementing biomarker strategies for clinical programs
- Extensive experience with biomarker assays, including working knowledge of assay validation principles and clinical sample collection, handling, and analysis workflows
- Strong written and verbal communication skills
- Ability to operate effectively and independently in a highly matrixed environment, collaborating across functions and providing scientific oversight of external partners
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