(Senior) Director, Clinical Quality Assurance

Organizational Overview:

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

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 in the IMVT-1401 program. This individual will have the unique opportunity to help grow and shape the IMVT-1401 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)
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 GCP culture in a start-up biotechnology company preferred
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 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
Position may be located at either Immunovant’s New York City or Durham office
Domestic and international travel required (up to 35%)