About This Role:
As a Principal Scientist in Clinical Biomarkers, you will play a pivotal role in the design, execution, and interpretation of biomarker activities across our clinical studies. Positioned within the West Coast Hub (WCH) team, you will work closely with Discovery Biomarkers, Clinical Development, Clinical Pharmacology, Biostatistics, Regulatory, and external CROs to ensure the timely delivery of high-quality biomarker data. This role is crucial in aligning study-level biomarker activities with program biomarker strategy, generating data that informs clinical development, regulatory submissions, and key program decisions. Your work will advance our understanding of solid organ transplants and enhance clinical trial outcomes. Within our highly matrixed environment, you will drive scientific and technical innovation, significantly contributing to the overall success of our projects.
What You’ll Do:
- Develop and implement comprehensive biomarker strategy for one or more clinical studies and provide strategic oversight to study-related documents.
- Drive the generation of analysis and interpretation of biomarker data in clinical studies, generating mechanistic insights to support program development.
- Author and review biomarker sections for study protocols, SAPs, and regulatory documents (CSR, IB, BLA).
- Identify fit-for-purpose biomarker assays for PD, MoA, MoR, and disease monitoring biomarkers to inform clinical development.
- Collaborate with internal SMEs on vendor selection, qualification, and technology transfer of biomarker assays, and oversee multiple outsourced projects with contract research laboratories and technology partners.
- Collaborate with Discovery Biomarkers, Clinical Development, Biometrics, Clinical Pharmacology, and other cross-functional teams to execute translational studies and analyze and interpret biomarker datasets.
- Stay current with emerging biomarker technologies and trends in transplant and immune-mediated diseases.
- Work effectively in a highly matrixed environment and contribute to decision-making through scientific communication, data-driven recommendations, and stakeholder engagement.
Who You Are:
You are a dynamic and innovative scientist with a passion for biomarker research. Your strong communication skills enable you to articulate complex scientific concepts clearly, and you thrive in collaborative environments. You are adept at independent problem-solving and are driven by a desire to contribute to advancements in clinical trials and regulatory processes. Your ability to stay informed about the latest biomarker technologies and trends ensures that you remain at the forefront of your field.
Required Skills:
- 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.
Preferred Skills:
- Experience supporting clinical trials, including contributing to regulatory filings and external communication documents.
- Experience in B cell immunology and/or clinical programs in nephrology and/or solid organ transplant.
