Senior Manager, Clinical Biomarker Operations - Remote

Overview

The Department of Research and Translational Medicine is seeking a Sr. Manager, Clinical Biomarker Operations. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, and contracts and budget management.

In Short

• Track and manage logistics around biomarker sample collection across all clinical trials.
• Develop robust processes for planning, coordination, and testing of clinical samples.
• Ensure high quality data generation by overseeing external collaborations.
• Maintain sample inventories and coordinate sample collection.
• Collaborate with stakeholders including Data Management, Clinical Operations, and Quality Assurance.
• Ensure adherence to clinical study protocols and oversee data transfer specifications.
• Support review and finalization of MSAs and legal agreements.
• Support QA in vendor audit and inspection activities.
• Manage biomarker budget planning and tracking of accruals.
• Continuously identify and build best practices for process improvements.

Requirements

• PhD with >3 years, MS with >6 years, or BS with >8 years in biomarker operations.
• Good understanding of biomarker assays and drug development.
• Prior experience in biomarker sample analysis with CROs and internal labs.
• Experience in I&I indications.
• Excellent communication skills and ability to manage timelines.
• Ability to manage multiple priorities under tight timelines.
• Exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, Egoless.
• Position requires approximately 10% travel.

Benefits

• Great culture grounded in C.O.R.E. values.
• Opportunity to work in a fast-paced environment.
• Market competitive compensation and benefits package.
• Flexible PTO.
• Two company-wide shutdowns each year.
• Commitment to professional growth and development.
• Regular in-person team meetings.