Senior Director, Clinical Quality Assurance - Remote

Overview

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

In Short

• Lead Clinical Quality Assurance (CQA) at Immunovant.
• Ensure compliance with global GCP regulations.
• Manage clinical quality assurance activities.
• Provide oversight for clinical trial partners.
• Develop strategic plans for quality systems.
• Promote a culture of quality across the company.
• Interact with regulatory authorities like FDA and EMA.
• Train and mentor staff on GCPs and Clinical Quality.
• Support clinical program design and execution.
• Lead engagements with regulatory authorities as needed.

Requirements

• Bachelor or Master’s degree in Biology, Chemistry, Nursing, or related fields.
• Minimum 8 years of GCP experience in quality assurance.
• Minimum 5 years in management roles in a biopharmaceutical environment.
• Experience managing Phase 1-3 clinical trials.
• Experience with FDA, EMA interactions.
• Strong analytical and organizational skills.
• Excellent communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience in immunology preferred.
• Ability to build strong relationships across departments.

Benefits

• Dynamic and fast-paced work environment.
• Remote-based position with access to NYC/NC offices.
• Domestic and international travel required (up to 35%).
• Full range of medical, dental, vision, and 401k benefits.
• Unlimited paid time off and parental leave.