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Biotech
The VP, Quality Operations at Alumis is responsible for developing and implementing strategies for GMP and GLP Quality functions. This leader manages a high-performing team, ensuring quality oversight in manufacturing and GLP testing, while collaborating with CMC and preclinical teams. The role requires extensive knowledge of regulations, quality management systems, and experience in quality assurance processes.
Biotech
The Director of Biostatistics at Alumis Inc. will provide statistical leadership for Phase 2 and 3 clinical trials, overseeing statistical analysis plans and ensuring quality in deliverables. This role involves hands-on contributions to clinical study reports and integrated analyses for regulatory submissions, and will mentor junior team members while managing CRO partners.
Biotech
The Director HR Business Partner will lead HR strategies to improve business performance and foster a positive workplace at Alumis Inc. This role includes collaborating with leaders, delivering HR programs, managing performance processes, and diagnosing organizational issues. They will provide strategic support for employee development and ensure a resilient, inclusive culture.
Biotech
The Associate Director, GMP QA will oversee quality operations for external vendors, ensuring compliance with GMP and quality regulations. Responsibilities include reviewing manufacturing and testing documentation, leading quality assessments, and promoting a culture of quality management within the organization.
Biotech
The Senior Manager of Statistical Programming will lead and validate statistical programming for clinical studies, ensuring compliance with regulatory requirements. Responsibilities include overseeing programming tasks, developing plans, reviewing documents, managing CRO activities, and improving programming processes, while actively contributing to drug development efforts.
Biotech
The Director of Program Management at Alumis Inc. will provide leadership and management for drug development projects, coordinate with project teams, identify risks and communicate effectively while ensuring alignment with strategic objectives. This role also involves managing project management tools and supporting business priorities within the organization.
Biotech
The Senior Vice President of Biometrics leads the strategic vision and operational execution of Biostatistics, Data Management, and Statistical Programming. The role involves developing biometrics strategies, overseeing clinical trial design and execution, ensuring high data quality and regulatory compliance, and fostering a collaborative culture within the biometrics team.
Biotech
The Director of Safety Surveillance will oversee safety surveillance activities, manage a team, develop strategies, and ensure compliance with regulatory requirements, conducting analyses and reporting safety data to support clinical and regulatory activities.
Biotech
The Director of Safety Operations at Alumis Inc. will lead the safety operations team, ensuring compliance with global regulatory requirements and managing the collection and submission of safety data. Responsibilities include oversight of vendor performance, development of safety policies and systems, and collaboration across various departments to support drug safety activities.
Biotech
The Associate Director of Data Management is responsible for managing clinical trial data, overseeing the execution of data management activities, ensuring compliance with industry standards, and leading initiatives like CRF design and data integration. This role includes vendor management and ensuring project deliverables are completed timely while maintaining quality.
Biotech
The Contract Senior Manager, Statistical Programming will lead the development and validation of statistical programs for late-stage clinical studies, ensuring compliance with SOPs and regulatory requirements, and delivering high-quality outputs. Responsibilities include support for NDA submissions, creation of programming plans, and development of macros to improve efficiency.
Biotech
The Senior Research Associate will execute in-house analytical lab activities, develop and validate analytical methods, operate and troubleshoot lab instruments, support outsourced testing, and review GMP analytical data. Responsibilities include maintaining clear documentation and effective communication about data accuracy.