Apply Description Position Summary:
The Senior Scientist will serve as the primary scientific and operational bridge between discovery research and clinical development. This role is responsible for the strategic design and execution of translational plans within clinical trials, ensuring that high-quality human samples are collected, processed, and analyzed to drive biomarker discovery and clinical decision-making.
Essential Responsibilities:
• Translational Strategy: Design and implement integrated translational and biomarker strategies to support clinical trials and patient selection. • Biomarker Development: Lead the identification, validation, and clinical application of pharmacodynamic and predictive biomarkers. • Operational Planning and Clinical Sample Lifecycle Management: Collaborate with Clinical Operations to author and manage laboratory manual and sample handling protocols; oversee the end-to-end logistics of clinical specimen collection, processing, shipment and long-term storage across multi-center sites. • CRO & Vendor Management: Identify and manage CROs; lead data transfer and validation of biomarker assays at external sites. • Cross-Functional Leadership: Represent the translational function on the clinical team, providing expert guidance on sample feasibility, site training, and data reconciliation. • Regulatory & Compliance: Draft translational sections for IND filings, Investigator Brochures (IB), and Clinical Study Reports (CSR). • Data Integration: Partner with Clinical Data Management and Data Scientist to ensure timely and accurate transfer of biomarker data into clinical databases for real-time analysis.
Qualifications
Education: PhD in life science or a related field with 5+ years of experience, or MS with 8+ years of experience in biotechnology or pharmaceutical preclinical or clinical development
Deep knowledge of biomarker operations and development specifically within a clinical trial framework
Proven track record of managing complex clinical sample logistics and troubleshooting site-level operational challenges
Experience in metabolic or dermatology diseases is preferred
Exceptional project management skills and the ability to influence cross-functional stakeholders in a fast-moving environment
Strong scientific rigor and experience in developing and validating biomarker assays, and designing biomarker studies
Organize data and evaluate data quality of studies
Manage external resources in a small company environment
Collaborate with R&D and clinical colleagues and participate as a member of the clinical study teams and development teams as appropriate
Effectively communicate and present results to various internal and external audiences
Demonstrates potential for a high level of proficiency, creativity, collaboration with others and independent thought process
Salary Range: $165,000-$180,000
Actual compensation within this range will be based on the experience and qualifications of the selected candidate.