Jobs at Apogee Therapeutics

Lead the statistical programming function for clinical trials, manage CRO relationships, and mentor team members while driving process improvements and ensuring quality deliverables.

The Clinical Trial Manager oversees global clinical trial programs, ensuring compliance to regulatory standards, managing vendor partnerships, and communicating project statuses while focusing on patient enrollment and data quality.

Manage regulatory project planning and execution for clinical trials, ensuring alignment across teams. Drive submissions and optimize regulatory processes.

The Manager of Clinical Business Operations oversees project planning for clinical programs, ensuring integration of operations, managing resources, and tracking performance metrics.

The Clinical Monitoring Manager oversees in-house CRAs and CROs for clinical trials, ensuring compliance and quality. They manage and support clinical study activities, liaise with stakeholders, and ensure trial readiness.

The Associate Director, Device Development will provide technical leadership in developing biologic/device combination products, oversee manufacturing and regulatory submissions, and collaborate with cross-functional teams.

The Associate Director will lead late-stage development and commercialization of monoclonal antibodies, focusing on process delivery and oversight with CDMO partners.

Manage the end-to-end clinical supply chain for multiple clinical programs, ensuring timely delivery of products while collaborating with various cross-functional teams and maintaining regulatory compliance.

Lead statistical programming for clinical trials, managing programmers and CROs. Oversee programming activities, ensuring timely support for clinical projects and developing programming processes.

The Director of GMP Quality Assurance will ensure quality compliance in biologics manufacturing, oversee audits, manage batch releases, and drive continuous improvement in quality systems.

The Associate Director will optimize clinical operations standards, enhance operational efficiency, and manage resources for global clinical trials, ensuring best practices and vendor performance.

The Senior Manager, Regulatory Affairs will oversee regulatory strategies, manage submissions to the FDA and international agencies, and coordinate with cross-functional teams to ensure compliance and timely submissions.

As Director of AI Enablement, you will lead Apogee's AI strategy, managing program operations, cross-functional collaboration, governance, and performance measurement to drive organization-wide AI literacy and adoption.

Manage logistics of biomarker sample collection, ensure adherence to clinical protocols, oversee data transfer, vendor management, and budget tracking for clinical trials.

Lead development and execution of scientific communications across therapeutic areas, manage publications and medical congress activities, coordinate MLR review, collaborate with cross-functional teams, and oversee external vendors to ensure compliant, high-quality dissemination of clinical and scientific data.

Lead and scale clinical data management systems and processes across programs. Oversee EDC/ePRO/RTSM/CTMS integrations, champion CDISC standards, manage CROs and external vendors, ensure GCP/ICH and regulatory compliance, deliver submission-ready datasets, build and mentor the DM team, and drive process improvement and technology adoption.

The Director of Clinical Development will oversee clinical trials in inflammation and immunology, collaborating with cross-functional teams, ensuring protocol adherence, and providing scientific insights for decision-making.

The Director of US Insights and Market Development will lead market research initiatives, develop strategies for pre-launch and brand activities, and integrate insights from various analytics to support decision-making within the Commercial team.

Manage clinical trial investigational medicinal product (IMP) supply and logistics: forecast demand, coordinate vendors, monitor inventory and shipments, support D&OP, ensure GMP/GDP/regulatory compliance, assist RFPs/budgeting/vendor performance, maintain SOPs, and support audits and cross-functional continuous improvement.

Lead the biostatistics efforts for clinical studies, providing technical guidance, statistical analysis, and overseeing CRO teams while ensuring regulatory compliance.