Immunovant
Teams at Immunovant
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Biotech
Lead biostatistics for multiple development programs: define and execute statistical strategy, contribute to protocols, SAPs, regulatory submissions, ensure compliance, apply innovative methods, collaborate cross-functionally, and manage study biostatisticians.
Biotech
Lead CMC Quality Assurance for sterile drug product manufacture and clinical packaging. Provide GMP/GxP oversight of CDMOs/CMOs, approve batch records, support process control strategy, data integrity, batch disposition, inspection readiness, regulatory filings, and continuous improvement using eQMS and quality systems to ensure compliance and patient safety.
