Associate Principal Scientist responsible for planning and executing biomarker operations for clinical trials at a global healthcare leader. Supporting drug development through operational excellence in Immunology and Oncology.
Responsibilities
Responsible for planning and executing clinical-trial biomarkers across the pipeline
Ensuring compliant, efficient biospecimen collection, assay execution, and data delivery
Drive operational excellence, data quality, and compliance across the biomarker assay project lifecycle
Partner closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research
Collaborate closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics
Serve as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs
Co-author biomarker-related sections of clinical study protocols
Collaborate with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements
Develop biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams
Work with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation
Partner with Data Management to transfer biomarker data from external vendors into the clinical data repository
Work with clinical teams and central laboratories to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors
Build and maintain effective partnerships with external biomarker vendors and internal company teams
Proactively identify and resolve conflicting stakeholders needs to maintain alignment and momentum
Implement and continuously improve streamlined workflows that maximize efficiency and data quality and reinforce a culture of operational excellence.
Requirements
Bachelor’s degree (with ≥8 years of relevant experience), Master’s degree, or higher (with ≥5 years of relevant experience) in a scientific or technical field.
Demonstrated project management experience.
Proven experience in drug discovery and/or clinical research.
Demonstrated ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
Excellent written and verbal communication skills, with the ability to work independently within a highly collaborative, matrixed environment.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
Job title
Associate Principal Scientist – Biomarker Operations
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