POSITION SUMMARY:

The Associate Director of Diagnostics will oversee the advancement of clinical biomarker assays toward either GCLP or CLIA utility. This will involve the oversight of either immunoassay or mass spectrometry-based platforms following regulated guidance. He/she will manage research associates/scientists as well as advance SOPs and maintain quality metrics within the workflow. The Associate Director of Diagnostics will also manage KOL relationships and external/internal projects through the publication of high-impact publications demonstrating the robustness of the bioanalytical workflows

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for the full spectrum of activities involved in analytical measurements with the group, including biomarker development as well as assisting with pharmacokinetic/pharmacodynamic oversight.
• Organize, analyze and report experimental output.
• Provide oversight for logistics on LDT assay development for critical reagents.
• Provide commercial insight and logistics on advancing assays toward commercial development and launch as well as developing a strategy for commercial operations
• Manage a team of research associates and scientists
• Maintain lab analytical instrumentation for routine maintenance.
• Assessment of daily QC activities and validated SOP implementation.
• Ensure all documentation and reporting is followed in accordance with regulatory policies and procedures.
• Other duties, as assigned.

REQUIREMENTS:

• Requires an MS/Ph.D. in analytical chemistry, biochemistry, or a related field with 7-8 years’ of experience in managing clinical and biomarker assays.
• Comprehensive understanding of managing a regulated bioanalytical laboratory.
• Excellent communication and interpersonal skills combined with a proven track record of technical and organizational skills.
• Must be able to work in a team-oriented environment and demonstrate attention to detail and record-keeping.
• Knowledge of Microsoft Word, Excel and PowerPoint required for the preparation of reports to management.
• Ability to prepare manuscripts for presentation, publication, and regulatory requirements is preferred.