Associate Director/Director, Translational Biology

The Associate Director of Biomarker Science will be leading assay development, validation, and translational biomarker strategies across BridgeBio affiliate programs. This role requires a hands-on scientific leader who can design and validate assays, integrate biomarkers into clinical development, manage vendor partnerships, and communicate results to internal and external stakeholders. The successful candidate will operate at the intersection of discovery, preclinical development and clinical operations- providing scientific leadership and operational rigor to accelerate program decision-making. This position includes supervisory responsibilities: you will both lead scientific work and manage a team of scientists and technical staff, providing coaching, career development, resource planning and performance management.

• Define the biology strategy to support target validation, mechanism-of-action studies, and medicinal chemistry optimization
• Design and execute in vitro and in vivo experiments that demonstrate target engagement, functional pharmacology and disease-relevant biology to inform med chem SAR and lead optimization
• Coordinate with medicinal chemistry, structural biology and pharmacology teams to prioritize compounds, define target product profiles, and support lead selection
• Translate discovery findings into criteria and experimental plans that feed into IND-enabling studies and inform go/no-go decision points

• Lead design, development and validation of biomarker and pharmacodynamic assays (cell-based, biochemical, ELISA/multiplex immunoassays, Western blotting, biophysical protein characterization, etc.) to support translational and clinical programs
• Set assay performance criteria and qualification/validation plans; author SOPs and validation reports; implement QA/QC practices to ensure reproducible assay performance

• Translate preclinical biomarker findings into clinical biomarker strategies and practical assay deployment plans
• Collaborate with clinical operations, sample management and biostatistics to design sample collection, processing, storage and chain-of-custody procedures
•  Oversee incorporation of biomarker testing into Phase 1–3 protocols, including sample handling, endpoint definitions and analysis plans

• Identify, qualify and manage relationships with external vendors, CROs and CLIA laboratories for assay development, transfer and routine execution
• Lead vendor qualification, technology transfer, assay bridging and vendor audits to ensure regulatory readiness and data quality

• Ensure biomarker assays and data collection comply with applicable regulatory standards (GCP/GLP where applicable)
• Contribute clinical assay sections and assay validation summaries for regulatory submissions (INDs, briefing packages, NDAs) and support responses to regulatory questions

• Partner with biostatistics to develop statistical analysis plans, define analytical endpoints and produce tables, listings and figures for decision-making and regulatory documents
• Oversee rigorous data capture, QC and reporting for clinical biomarker datasets and preclinical/clinical study reports
• Contribute to statistical analysis plans and the design of tables, listings, and figures

• Prepare and present scientific reports, publications and conference abstracts; engage with key opinion leaders to inform biomarker strategy
• Present translational data to program teams and senior leadership; mentor and develop early-career scientists
• Support internal initiatives to capture lessons learned, propagate best practices and continuously improve biomarker workflows
• Collaborate with drug discovery, clinical development, and regulatory affairs teams to integrate biomarker strategies
• Present data to the broader MLBio team, including scientific, clinical, and business leaders

This role involves primarily hands-on laboratory responsibilities in our San Carlos, CA location.

• Minimum Education requirement:
• M.S. or Ph.D. in Biology, Biochemistry, Molecular Biology or a related discipline.

• Minimum 10 years of industry experience in translational science, biomarker development, or related roles supporting clinical development.
• Demonstrated track record developing and validating cell-based and biochemical assays for clinical use; experience with ELISA, multiplex immunoassays, Western blotting and protein characterization methods.
• Hands-on experience with assay transfer to CRO labs, vendor qualification, and supporting regulatory filings.
• Strong understanding of clinical study design, GCP, and regulatory expectations for biomarker data.
• Experience writing scientific and regulatory documents and collaborating with cross-functional teams including biostatistics.

• Strong scientific judgment and experimental design skills; ability to interpret complex datasets and provide clear, actionable recommendations.
• Excellent written and oral communication; experience presenting to scientific and business audiences.
• Proven leadership and mentorship skills; collaborative, proactive and team-oriented approach.
• Detail-oriented with strong project management abilities and a commitment to high quality data and documentation.

• Travel for vendor management/audits and scientific meetings as required.