Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, Batoclimab and IMVT-1402, are both novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, both are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Associate Director of CQA who will lead the management of GCP quality activities in support of one or more clinical programs and trials (from Phase 1 to 4 including non-interventional studies) to drive proactive quality management, and ensure compliance with corporate policies and functional procedures, and applicable regulations for ensuring the protection of the rights, welfare, well-being, and personal data privacy of subjects, data integrity, and GCP regulatory compliance. The position will report to the Sr. Director, Clinical Quality Assurance and will be based remotely.
As the primary GCP quality point-of-contact cross-functionally for the assigned clinical program(s), the Associate Director of CQA will be responsible for establishing and executing a fit-for-purpose, phase-appropriate audit program with the goal of submission-ready quality data, first pass approvals by competent authorities for marketing authorizations, and commercializing Immunovant products. This individual contributor will be instrumental in integrating quality and compliance strategy and establishing useful tools in tracking and trending key quality and compliance metrics to drive continuous improvement throughout the lifecycle of the clinical development process across all clinical program portfolio at Immunovant. This position will serve as a key prep./ready-room function during competent authority GCP inspections of Immunovant.
- Contributes to the planning, management, and performance of GCP audits of Phase 1-3 clinical trials, e.g., clinical investigator sites, vendors/CROs, internal system/processes and clinical documents or data, including CAPA evaluation and follow-up.
- Represent Clinical Quality Assurance at cross-functional clinical program meetings, Clinical Study Team meetings, and operational activities to provide appropriate Quality guidance on GCP compliance and continuous improvement matters to internal departments.
- Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
- Develop and sustain collaborative relationships with operational study peers.
- Author, maintain and implement study-specific Clinical Quality Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase-appropriate, fit-for-purpose audit program.
- Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
- Oversee the implementation of appropriate and timely CAPAs.
- Participate in risk review meetings and review study Risk Management Plans.
- Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Clinical Study Reports, Investigator’s Brochure, for ensuring quality, accuracy, and completeness.
- Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls.
- Identify process improvements to build compliance into the design and conduct of clinical activities.
- Actively support the development and deployment of activities to ensure documentation is inspection ready at all times.
- Bachelor or Master’s degree in Life Sciences or related fields
- Five to eight (5-8) years of Quality Assurance experience, with a minimum of 2 years specifically in GCP focused clinical quality assurance
- A minimum of two (2) years managing Phase 1-3 clinical trials (experience in immunology trials is strongly preferred)
- Direct experience in Data Management or Biostatistics is a plus.
- Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly U.S. FDA/EU and ICH regulations and guidelines
- Direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAIs), etc.
- Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations
- Comprehensive knowledge of the interrelationship among other Quality functions (CMC Quality, Quality Systems, Audit Management, Vendor Management) and other business functional areas (Biostatistics, Clinical Development, Clinical Operations, Clinical Laboratory, CMC Operations, Data Management, Drug Safety and Pharmacovigilance, Regulatory, Supply Chain, and Program Management) to serve as a good business partner
- Experience with international clinical study compliance preferred
- Passionate/highly motivated individual, self-driven and able to hit the ground running
- Able to consistently produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
- Excellent communications skills, both written and verbal
- Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally
- Strategic thinker, open-minded and flexible to adopting new ideas and emerging technologies
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Remote based: (note: IMVT has offices in both New York City and Durham, NC and occasional travel to these locations may be required)
- Domestic and international travel required (up to 25%)
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, 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 $135,000 - $189,360