Senior Director, Clinical Quality Assurance (CQA)

Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in neonatal fragment crystallizable receptor (FcRn) inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the FcRn. Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

Immunovant is seeking a Senior Director, Clinical Quality Assurance (CQA) to serve as a key leader in Quality on a highly dynamic, cross-functional team. The position reports to the Vice President & Head of Quality with responsibility for leading Clinical Quality Assurance (CQA) with a critical role in delivering high-quality clinical results while ensuring compliance with global GCP regulations across multiple indications. This individual will have the unique opportunity to help grow and shape the quality team, quality systems, and clinical processes at a rapidly growing biotechnology company.

The Senior Director, Clinical Quality Assurance (CQA) provides global GCP oversight and direction for Immunovant Clinical Operations to ensure regulatory compliance with FDA, EMA, and other applicable global health authority requirements that ultimately ensure patient safety. This role also provides strategic planning for continuous improvement efforts, reporting/escalation of critical quality issues, conducting risk mitigation for clinical trial activities, and ensuring a compliant culture of quality through effective leadership with strong adherence to Immunovant’s key value pillars.

This position will contribute to Immunovant’s success by managing all clinical quality assurance activities under the guidance of the Head of Quality, while working closely across functions at Immunovant and in partnership with external global vendors including CROs and clinical sites. The Senior Director, Clinical Quality Assurance (CQA) will also participate in strategic planning with a focus on meeting corporate quality goals, promoting a culture of quality across the company, and reflecting Immunovant’s core values as a leader.

Key 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)Immunovant, Inc.

• 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.

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

• Experience interacting with FDA, EMA, and other global health authorities

• 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

Personal Characteristics:

• 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 the 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

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment

• Immunovant’s headquarters is located in New York City. The position is flexible for remote work.

• Domestic and international travel required (up to 35%)

Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $240,000.00 - $265,000.00.