Senior Director, Clinical Quality Assurance

Summary

Join Immunovant, a clinical-stage immunology company, as their Senior Director, Clinical Quality Assurance (CQA). This key leadership role reports to the SVP & Head of Quality, overseeing global GCP compliance across multiple indications. You will lead CQA efforts, ensuring high-quality clinical results and regulatory compliance with FDA, EMA, and other global health authorities. This position involves strategic planning, risk mitigation, and fostering a compliant quality culture. You will manage clinical quality assurance activities, collaborate with internal and external partners, and participate in strategic planning to meet corporate quality goals. The role requires significant experience in GCP, managing clinical trials, and interacting with regulatory authorities. Immunovant offers a competitive salary, equity, and a comprehensive benefits package.

Requirements

• Bachelor or Master’s degree in Biology, Chemistry, Nursing, or related fields
• A minimum of eight (8) years of GCP experience with a focus on quality with substantial operational and clinical quality assurance experience
• A minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; a minimum of two (2) years managing Phase 1-3 clinical trials
• A minimum of three (3) years supervising and managing people and teams
• Experience interacting with FDA, EMA and other global health authorities
• Strong analytical and organizational skills, with attention to detail
• Excellent written, verbal, listening and interpersonal communication skills
• Ability to professionally interface with all levels (e.g. senior-level executives, staff, colleagues, external partners, consultants)
• Integrated Quality leader with ability to build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance
• Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
• Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity and discretion at all times

Responsibilities

• Provide quality leadership for Clinical Quality Assurance with authority for ensuring GCP compliance for the clinical programs at Immunovant
• Lead efforts to evaluate and contribute to clinical program design and execution (e.g., protocols, ICFs, CAPAs, CSRs)
• Provide oversight and/or management of clinical trial partners [e.g. contracted Clinical Research Organizations (CROs), contractors]; identification and onboarding of new third-party partners as necessary
• Provide strong leadership in support of Good Clinical Practices (GCPs) with significant operational, clinical and quality experience as related to monoclonal antibodies therapies
• Ensure that Immunovant and its partners are inspection-ready by global World Health Authorities including FDA and EMA
• Assist in preparation, review and approval of clinical regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with SOPs, Clinical Quality processes and regulatory standards
• Oversee development and maintenance of clinical SOPs related to GCP activities
• Develop strategic plans using a Quality Systems approach to accommodate department and Quality division growth and lead the clinical operations team toward successful implementation and execution of the systems
• Coordinate with other departments within Immunovant to establish and improve policies and procedures for Clinical Quality ensuring compliance with Immunovant’s QMS
• Lead engagements with regulatory authorities for Immunovant as needed, especially as related to Clinical Quality; provide direct oversight of Clinical Quality activities
• Participate in strategic planning with a focus on meeting corporate quality goals
• Promote a culture of quality across the company and reflect Immunovant’s core values as a leader; train/mentor staff cross-departmentally on GCPs and Clinical Quality as needed

Preferred Qualifications

• Experience with building a GCxP culture in a start-up biotechnology company preferred throughout a company
• Experience in immunology with clinical trials is strongly preferred

Benefits

• Full range of medical, dental, vision
• 401k
• Other benefits
• Unlimited paid time off
• Parental leave
• Equity and other forms of compensation may be provided as part of a total compensation package
• Remote-based; will have access to Immunovant’s NYC/NC offices