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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 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.

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 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.