Jobs at Apogee Therapeutics

The Associate Director, Analytical Development will lead activities related to analytical methods for biologics, manage experiments, and collaborate with cross-functional teams, while ensuring compliance with quality and regulatory standards.

The Senior Director of Commercial Strategy will lead the development and execution of the U.S. commercialization roadmap, collaborating with cross-functional teams and managing competitive intelligence processes.

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

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

The Senior Manager will manage operational and planning aspects of medical congress and publication activities, ensuring compliant delivery of scientific communication materials and cross-functional collaboration.

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 leads QC analytical testing, ensuring compliance with regulations, managing method validations, and collaborating on regulatory submissions.

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.

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

The Senior Manager of Clinical Systems oversees clinical technology initiatives, manages clinical systems projects, ensures compliance, and promotes process adoption across multiple functions while collaborating with various stakeholders.

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

The Executive Director of GMP Quality Assurance oversees the GMP QA strategy, ensuring compliance with global regulations, leading a high-performing team, and preparing for regulatory inspections and audits.

Lead design, planning, execution, and quality oversight of clinical trial data management (Phase I-IV). Manage CROs and vendors, ensure EDC/eCRF/ CDM standards, support database locks/snapshots, collaborate with Biostatistics/Programming and other functions, and maintain regulatory-ready documentation for submissions.