Senior Manager, Clinical Biomarker Operations
Plan biomarker sample logistics across clinical trials; oversee vendor testing, data delivery timelines, and final sample disposition.
- Remote
- Full Time
- $150,000 – $170,000/year
- Min. 3 YOE
Browse the full live job inventory for Apogee Therapeutics. This page is focused on current openings, while the overview tab highlights role groups and hiring patterns.
Plan biomarker sample logistics across clinical trials; oversee vendor testing, data delivery timelines, and final sample disposition.
Oversees in-house CRAs and CRO monitoring to ensure study quality, data integrity, and regulatory compliance.
Director leads GMP QA programs to ensure compliance, audits and ongoing quality improvements for biologics manufacturing.
Lead end-to-end clinical supply planning, procurement, and distribution for global trials with GMP/GDP compliance.
Lead operation standards, planning and optimization across global clinical trials, ensuring efficient resource use and CRO oversight.
Senior QA leader driving global GMP strategy, audits, and external partner oversight to enable scale.
Provides project planning support for dermatology or respiratory clinical programs to maintain study plans and drive cross-functional execution.
Lead QC analytical testing, method lifecycle activities, and data review to ensure cGMP compliance across development pipeline.
Senior Manager of Clinical Systems leads end-to-end clinical system initiatives, including IRT, CTMS, and eCOA implementations and cross-functional delivery.
Plan biomarker sample logistics, oversee CRO testing, and manage data transfer with cross-functional collaboration.
Senior Director leads development of strategic commercial plan and cross-functional go-to-market for lead asset in Atopic Dermatitis.
Lead analytical development for monoclonal antibodies and biologics across development stages, coordinating internal/external partners.
Lead statistical design/analysis for clinical studies, oversee vendor biostatistics teams, and contribute to regulatory submissions.
Lead MSAT activities for late-stage biologics, driving tech transfer, DS campaigns, and PPQ strategies with CDMOs.
Lead and expand MSL team in the East; coach, develop, and align field medical affairs with dermatology strategy.
Lead regulatory submissions and team coordination for FDA and ex-US agencies, ensuring timely, compliant documentation and publishing.
Lead PFS process development and manufacturing, oversee tech transfer to CDMOs, and deliver robust drug product supply for clinical trials and launch across biologics.
Oversee global clinical trial programs (Phases I-III) focusing on CRO/vendor collaboration, data quality, and regulatory readiness.
Senior role coordinating medical congress activities, publications tracking, and cross-functional ops in regulated environment.
Lead statistical programming activities for clinical trials, manage CROs, and build processes.
Lead global regulatory submission planning and coordination, optimizing cross-regional delivery and PMO governance.
Lead data management activities for clinical trials, overseeing data collection, quality, and CRO partnerships.