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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, contracts, and budget management.
Job Responsibility:
Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition
Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications
Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions
Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance
Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships
Support QA in vendor audit and inspection activities
Support activities related to biomarker budget planning and tracking of accruals
Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards
Continuously identify and build best practices for process improvements
Ensure high quality data generation by overseeing sample integrity and external collaborations
Requirements:
MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role
Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage
Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities
Experienced in all phases of clinical trials, Phase 3 experience is an asset
Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general
High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines
Experience in I&I indications
Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines
Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops
This position requires direct biotech or pharmaceutical industry experience. Do you have at least 4 years of experience working in a biotech or pharmaceutical company?
What we offer:
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve