Associate Director/Director, Translational Biology

Responsibilities

• Discovery & Biology Strategy
• 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
• Assay Development and Validation:
• 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
• Clinical Trial Support:
• 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
• Vendor Management:
• 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
• Regulatory Compliance and Filings:
• 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
• Data Management and Analysis:
• 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
• Scientific Communication & Leadership
• 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

Additional Information

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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