Senior Director - Clinical Quality Assurance

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Immunovant

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Description

• Organize and ensure GCP compliance for clinical programs • Lead efforts on clinical program design execution • Provide oversight for clinical trial partners • Ensure inspection readiness by global health authorities • Assist in clinical regulatory filings and safety data compliance • Develop strategic plans for Quality Systems approach • Coordinate with departments to establish compliance policies • Engage with regulatory authorities as needed • Promote a culture of quality across the company

Requirements

• Bachelor or Master’s degree in Biology, Chemistry, Nursing, or related fields • Minimum of eight (8) years of GCP experience with focus on quality • Minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical environment • Minimum of two (2) years managing Phase 1-3 clinical trials • Experience interacting with FDA, EMA, and other global health authorities • Building a GCxP culture in a start-up biotechnology company preferred • Experience in immunology with clinical trials strongly preferred

Benefits

• Unlimited paid time off • Parental leave • Medical, dental, and vision benefits • 401k plan • Equity opportunities