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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.