Plan track and manage biomarker sample logistics across all our clinical trials, oversee sample shipment and testing at vendors, complete 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, ICF and lab manuals, and oversee finalization of data transfer specifications.
Support the setup and ongoing management of a sample inventory database. This includes participating in the development of a biomarker sample inventory strategy, selecting third-party vendors for long-term sample storage, overseeing the tracking of sample collection, and coordinating shipment of samples to external testing partners
Support Biomarker related QA activities, including participating in gap analysis of biomarker departmental processes as part of inspection readiness
Coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Finance, Procurement and Quality Assurance.
Support activities related to biomarker budget planning and tracking of accruals.
Lead vendor selection, performance management and oversight to ensure compliance to Apogee standards
Continuously identify and build best practices for process improvements.

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 through 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
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.
Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines.
Successfully exhibit 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.

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

Senior Manager, Clinical Biomarker Operations

Key skills