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Oversee clinical trial quality and compliance for a biotech firm developing cancer therapies, ensuring adherence to GCP standards and regulatory requirements.
Oversee global regulatory submissions and project plans for oncology drugs, coordinating cross-functional teams to meet compliance and approval timelines.
Lead statistical design and analysis for oncology clinical trials, real-world evidence, and health economics studies using SAS/R, while partnering with cross-functional teams to generate data-driven insights for RAS-targeted cancer therapies.
Oversee oncology clinical trials for a biotech firm, ensuring compliance with regulations and managing cross-functional teams to deliver therapies for RAS-addicted cancers.
Oversee Good Laboratory Practice (GLP) compliance for a clinical oncology company, auditing internal and external vendors to ensure regulatory adherence for RAS-targeted cancer therapies.
Leads statistical analysis and data science for oncology drug development, designing models, mentoring teams, and supporting regulatory submissions using SAS/R.
Leads global regulatory filings for late-stage oncology drugs, coordinating cross-functional teams to prepare and submit NDA/MAA applications under expedited pathways.
Leads US regulatory filings (NDA/MAA) for late-stage oncology drugs, coordinating cross-functional teams and advising on expedited pathways to secure approvals for RAS-targeted therapies.
Leads global GCP QA strategy for late-stage oncology clinical trials, ensuring regulatory compliance, audit readiness, and patient safety while overseeing vendor quality and inspection outcomes.
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON)…
Principal Statistical Analyst at Revolution Medicines designs and validates SAS-based clinical datasets and reports for oncology trials, ensuring CDISC compliance and regulatory submission readiness.
Leads oncology clinical trials for a biotech firm, overseeing operations, budgets, and cross-functional teams to advance novel cancer therapies.
Senior Product Manager to lead chemistry-focused product strategy, workflows, and AI-enabled tools for oncology drug discovery at a late-stage clinical biotech company.
Oversee global GxP document control for a biotech firm, ensuring compliance with regulatory standards while managing document lifecycles and workflows in an electronic system.
Senior Machine Learning Scientist in drug discovery, building AI models to predict drug efficacy and toxicity using Python, PyTorch, and cheminformatics tools.
Oversee Japan’s regulatory strategy for oncology drugs, interfacing with PMDA and global teams to guide clinical development, submissions, and approvals for RAS-targeted therapies.
Evaluates and oversees drug safety data for cancer therapies, ensuring compliance with global regulations and protecting patient welfare through medical review of adverse events and regulatory submissions.
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